Trial Outcomes & Findings for Local Changes of Skin Characteristics After an Application of a Topical Product With a Warming or Cooling Effect (NCT NCT03016221)
NCT ID: NCT03016221
Last Updated: 2026-06-16
Results Overview
Local skin perfusion was measured with laser speckle contrast imaging (LSCI). The LSCI system uses arbitrary units to express the mean flux in the specified regions of interest which is related to the concentration of circulating erythrocytes in the tissue sample volume, scaled from blue (low perfusion) to red (high perfusion).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
during 45min post application
Results posted on
2026-06-16
Participant Flow
A total of 21 healthy women were recruited. On each participant, two skin areas (5 cm × 10 cm) were marked on either side of the thoracic spine. Methyl salicylate gel was applied to one side, while a placebo gel was applied simultaneously to the opposite side. Thus, this was a "split-person" design, with each participant serving as her own control.
The project originally planned to include several comparative experiments. However, due to personal and financial constraints, only one experiment was completed by the end of the study period. Owing to competing academic priorities, the study was not extended and was therefore concluded at that point.
Unit of analysis: skin area next to thoracic spine
Participant milestones
| Measure |
Healthy Women Receiving Topical Application of Methyl Salicylate and Placebo Gels
Healthy women participated. Two adjacent skin areas were marked on the thoracic spine (Th4-Th7). On one side, a methyl salicylate gel (Perskindol Dolo Gel-based formulation) was applied; on the other side, a placebo gel was applied.
Methyl salicylate gel composition: natural wintergreen oil (12.9%), hydroxyethyl cellulose (5%), water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol.
Placebo gel composition: hydroxyethyl cellulose, water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol. The placebo gel differed only by the absence of natural wintergreen oil.
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|---|---|
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Overall Study
STARTED
|
21 42
|
|
Overall Study
Methyl Salicylate Gel
|
21 21
|
|
Overall Study
Placebo Gel
|
21 21
|
|
Overall Study
COMPLETED
|
21 42
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Women Receiving Topical Application of Methyl Salicylate and Placebo Gels
n=21 Participants
Healthy women participated. Two adjacent skin areas were marked on the thoracic spine (Th4-Th7). On one side, a methyl salicylate gel (Perskindol Dolo Gel-based formulation) was applied; on the other side, a placebo gel was applied.
Methyl salicylate gel composition: natural wintergreen oil (12.9%), hydroxyethyl cellulose (5%), water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol.
Placebo gel composition: hydroxyethyl cellulose, water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol. The placebo gel differed only by the absence of natural wintergreen oil.
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|---|---|
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Age, Continuous
|
22.2 years
STANDARD_DEVIATION 2.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: during 45min post applicationPopulation: 21 participants received methyl salicylate gel on a 5 cm × 10 cm skin area on one side of the thoracic spine and placebo gel on the other side; the side was randomized.
Local skin perfusion was measured with laser speckle contrast imaging (LSCI). The LSCI system uses arbitrary units to express the mean flux in the specified regions of interest which is related to the concentration of circulating erythrocytes in the tissue sample volume, scaled from blue (low perfusion) to red (high perfusion).
Outcome measures
| Measure |
Healthy Women Receiving Topical Application of Methyl Salicylate and Placebo Gels
n=21 Participants
Healthy women participated. Two adjacent skin areas were marked on the thoracic spine (Th4-Th7). On one side, a methyl salicylate gel (Perskindol Dolo Gel-based formulation) was applied; on the other side, a placebo gel was applied.
Methyl salicylate gel composition: natural wintergreen oil (12.9%), hydroxyethyl cellulose (5%), water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol.
Placebo gel composition: hydroxyethyl cellulose, water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol. The placebo gel differed only by the absence of natural wintergreen oil.
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|---|---|
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Local Skin Perfusion
Methyl salicylate: T10
|
187.6 % of baseline MCskin
Standard Deviation 41.83
|
|
Local Skin Perfusion
Methyl salicylate: T15
|
158.05 % of baseline MCskin
Standard Deviation 31.72
|
|
Local Skin Perfusion
Methyl salicylate: T0
|
107.73 % of baseline MCskin
Standard Deviation 24.26
|
|
Local Skin Perfusion
Methyl salicylate: T5
|
188.7 % of baseline MCskin
Standard Deviation 47.82
|
|
Local Skin Perfusion
Methyl salicylate: T20
|
138.26 % of baseline MCskin
Standard Deviation 28.29
|
|
Local Skin Perfusion
Methyl salicylate: T25
|
123.37 % of baseline MCskin
Standard Deviation 27.19
|
|
Local Skin Perfusion
Methyl salicylate: T30
|
112.91 % of baseline MCskin
Standard Deviation 22.26
|
|
Local Skin Perfusion
Methyl salicylate: T35
|
104.23 % of baseline MCskin
Standard Deviation 18.14
|
|
Local Skin Perfusion
Methyl salicylate: T40
|
101.68 % of baseline MCskin
Standard Deviation 16.27
|
|
Local Skin Perfusion
Methyl salicylate: T45
|
96.96 % of baseline MCskin
Standard Deviation 16.66
|
|
Local Skin Perfusion
Placebo gel: T0
|
94.2 % of baseline MCskin
Standard Deviation 16.52
|
|
Local Skin Perfusion
Placebo gel: T5
|
82.49 % of baseline MCskin
Standard Deviation 8.62
|
|
Local Skin Perfusion
Placebo gel: T10
|
82.44 % of baseline MCskin
Standard Deviation 14.3
|
|
Local Skin Perfusion
Placebo gel: T15
|
81.03 % of baseline MCskin
Standard Deviation 12.44
|
|
Local Skin Perfusion
Placebo gel: T20
|
78.83 % of baseline MCskin
Standard Deviation 11.1
|
|
Local Skin Perfusion
Placebo gel: T25
|
79.76 % of baseline MCskin
Standard Deviation 12.75
|
|
Local Skin Perfusion
Placebo gel: T30
|
78.28 % of baseline MCskin
Standard Deviation 11.05
|
|
Local Skin Perfusion
Placebo gel: T35
|
84.56 % of baseline MCskin
Standard Deviation 16.12
|
|
Local Skin Perfusion
Placebo gel: T40
|
83.37 % of baseline MCskin
Standard Deviation 12.47
|
|
Local Skin Perfusion
Placebo gel: T45
|
85.32 % of baseline MCskin
Standard Deviation 11.54
|
PRIMARY outcome
Timeframe: At baseline and during 45 minutes post applicationPopulation: 21 participants received methyl salicylate gel on a 5 cm × 10 cm skin area on one side of the thoracic spine and placebo gel on the other side; the side was randomized.
skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
Outcome measures
| Measure |
Healthy Women Receiving Topical Application of Methyl Salicylate and Placebo Gels
n=21 Participants
Healthy women participated. Two adjacent skin areas were marked on the thoracic spine (Th4-Th7). On one side, a methyl salicylate gel (Perskindol Dolo Gel-based formulation) was applied; on the other side, a placebo gel was applied.
Methyl salicylate gel composition: natural wintergreen oil (12.9%), hydroxyethyl cellulose (5%), water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol.
Placebo gel composition: hydroxyethyl cellulose, water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol. The placebo gel differed only by the absence of natural wintergreen oil.
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|---|---|
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Skin Surface Temperature
Methyl salicylate: BL
|
33.7 degrees Celsius
Standard Deviation 0.93
|
|
Skin Surface Temperature
Methyl salicylate: T0
|
30.44 degrees Celsius
Standard Deviation 0.71
|
|
Skin Surface Temperature
Methyl salicylate: T5
|
30.34 degrees Celsius
Standard Deviation 0.98
|
|
Skin Surface Temperature
Methyl salicylate: T10
|
30.84 degrees Celsius
Standard Deviation 1.32
|
|
Skin Surface Temperature
Methyl salicylate: T15
|
31.53 degrees Celsius
Standard Deviation 1.05
|
|
Skin Surface Temperature
Methyl salicylate: T20
|
31.91 degrees Celsius
Standard Deviation 0.91
|
|
Skin Surface Temperature
Methyl salicylate: T25
|
32.17 degrees Celsius
Standard Deviation 0.83
|
|
Skin Surface Temperature
Methyl salicylate: T30
|
32.35 degrees Celsius
Standard Deviation 0.71
|
|
Skin Surface Temperature
Methyl salicylate: T35
|
32.48 degrees Celsius
Standard Deviation 0.76
|
|
Skin Surface Temperature
Methyl salicylate: T40
|
32.54 degrees Celsius
Standard Deviation 0.8
|
|
Skin Surface Temperature
Methyl salicylate: T45
|
32.57 degrees Celsius
Standard Deviation 0.82
|
|
Skin Surface Temperature
Placebo gel:BL
|
33.71 degrees Celsius
Standard Deviation 0.8
|
|
Skin Surface Temperature
Placebo gel: T0
|
30.54 degrees Celsius
Standard Deviation 0.68
|
|
Skin Surface Temperature
Placebo gel: T5
|
29.81 degrees Celsius
Standard Deviation 0.85
|
|
Skin Surface Temperature
Placebo gel: T10
|
29.95 degrees Celsius
Standard Deviation 1.14
|
|
Skin Surface Temperature
Placebo gel: T15
|
30.5 degrees Celsius
Standard Deviation 1.42
|
|
Skin Surface Temperature
Placebo gel: T20
|
31.06 degrees Celsius
Standard Deviation 1.48
|
|
Skin Surface Temperature
Placebo gel: T25
|
31.47 degrees Celsius
Standard Deviation 1.34
|
|
Skin Surface Temperature
Placebo gel: T30
|
31.78 degrees Celsius
Standard Deviation 1.15
|
|
Skin Surface Temperature
Placebo gel: T35
|
32.1 degrees Celsius
Standard Deviation 1.04
|
|
Skin Surface Temperature
Placebo gel: T40
|
32.27 degrees Celsius
Standard Deviation 0.91
|
|
Skin Surface Temperature
Placebo gel: T45
|
32.4 degrees Celsius
Standard Deviation 0.91
|
PRIMARY outcome
Timeframe: At baseline and during 45 min post applicationPopulation: 21 participants received methyl salicylate gel on a 5 cm × 10 cm skin area on one side of the thoracic spine and placebo gel on the other side; the side was randomized.
local muscle tissue oxygenation will be measured with near infrared spectroscopy
Outcome measures
| Measure |
Healthy Women Receiving Topical Application of Methyl Salicylate and Placebo Gels
n=21 Participants
Healthy women participated. Two adjacent skin areas were marked on the thoracic spine (Th4-Th7). On one side, a methyl salicylate gel (Perskindol Dolo Gel-based formulation) was applied; on the other side, a placebo gel was applied.
Methyl salicylate gel composition: natural wintergreen oil (12.9%), hydroxyethyl cellulose (5%), water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol.
Placebo gel composition: hydroxyethyl cellulose, water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol. The placebo gel differed only by the absence of natural wintergreen oil.
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|---|---|
|
Local Muscle Tissue Oxygenation
Placebo gel: T15
|
73.9 % SmO2
Standard Deviation 3.0
|
|
Local Muscle Tissue Oxygenation
Placebo gel: T20
|
73.1 % SmO2
Standard Deviation 2.6
|
|
Local Muscle Tissue Oxygenation
Placebo gel: T25
|
72.9 % SmO2
Standard Deviation 2.8
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|
Local Muscle Tissue Oxygenation
Placebo gel: T30
|
72.8 % SmO2
Standard Deviation 3.1
|
|
Local Muscle Tissue Oxygenation
Placebo gel: T35
|
72.2 % SmO2
Standard Deviation 3.0
|
|
Local Muscle Tissue Oxygenation
Placebo gel: T40
|
72.3 % SmO2
Standard Deviation 3.1
|
|
Local Muscle Tissue Oxygenation
Placebo gel: T45
|
72.9 % SmO2
Standard Deviation 2.8
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T10
|
74.9 % SmO2
Standard Deviation 2.1
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T15
|
73.6 % SmO2
Standard Deviation 3.2
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T20
|
73.6 % SmO2
Standard Deviation 3.6
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T25
|
73.5 % SmO2
Standard Deviation 2.9
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|
Local Muscle Tissue Oxygenation
Methyl salicylate: T30
|
73.2 % SmO2
Standard Deviation 2.3
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T35
|
72.8 % SmO2
Standard Deviation 2.8
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T40
|
73.0 % SmO2
Standard Deviation 3.3
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T45
|
73.2 % SmO2
Standard Deviation 2.6
|
|
Local Muscle Tissue Oxygenation
Placebo gel:BL
|
73.4 % SmO2
Standard Deviation 3.0
|
|
Local Muscle Tissue Oxygenation
Placebo gel: T0
|
73.7 % SmO2
Standard Deviation 2.6
|
|
Local Muscle Tissue Oxygenation
Placebo gel: T5
|
74.1 % SmO2
Standard Deviation 2.8
|
|
Local Muscle Tissue Oxygenation
Placebo gel: T10
|
73.9 % SmO2
Standard Deviation 3.2
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: BL
|
73.3 % SmO2
Standard Deviation 2.6
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T0
|
74.0 % SmO2
Standard Deviation 3.3
|
|
Local Muscle Tissue Oxygenation
Methyl salicylate: T5
|
75.1 % SmO2
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: At baseline and during 45 minutes post applicationPopulation: 21 participants received methyl salicylate gel on a 5 cm × 10 cm skin area on one side of the thoracic spine and placebo gel on the other side; the side was randomized.
Thermal sensation ("How does this feel like?") was assessed in each skin area according to the ISO 10551 standard using the following 9-point Likert scale: 4 = very hot, 3 = hot, 2 = warm, 1 = slightly warm, 0 = neutral,-1 = slightly cool,-2 = cool,-3 = cold,-4 = very cold.
Outcome measures
| Measure |
Healthy Women Receiving Topical Application of Methyl Salicylate and Placebo Gels
n=21 Participants
Healthy women participated. Two adjacent skin areas were marked on the thoracic spine (Th4-Th7). On one side, a methyl salicylate gel (Perskindol Dolo Gel-based formulation) was applied; on the other side, a placebo gel was applied.
Methyl salicylate gel composition: natural wintergreen oil (12.9%), hydroxyethyl cellulose (5%), water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol.
Placebo gel composition: hydroxyethyl cellulose, water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol. The placebo gel differed only by the absence of natural wintergreen oil.
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|---|---|
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Subjective Temperature Sensation
Methyl salicylate: T35 · neutral
|
9 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T45 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T45 · warm
|
1 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T45 · slightly warm
|
4 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T45 · neutral
|
14 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T0 · neutral
|
7 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T0 · slightly cool
|
11 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T0 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T5 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T20 · slightly warm
|
3 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T30 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T35 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T35 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T35 · slightly warm
|
2 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T40 · slightly warm
|
1 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T40 · neutral
|
18 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T45 · slightly warm
|
1 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T45 · neutral
|
18 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T45 · slightly cool
|
2 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T45 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: BL · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: BL · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: BL · slightly warm
|
1 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: BL · neutral
|
16 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: BL · slightly cool
|
4 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: BL · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T0 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T0 · warm
|
3 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T0 · slightly warm
|
4 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T0 · neutral
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T0 · slightly cool
|
11 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T0 · cool
|
3 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T5 · hot
|
1 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T5 · warm
|
5 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T5 · slightly warm
|
4 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T5 · neutral
|
1 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T5 · slightly cool
|
4 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T5 · cool
|
6 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T10 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T10 · warm
|
2 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T10 · slightly warm
|
6 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T10 · neutral
|
4 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T10 · slightly cool
|
6 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T10 · cool
|
3 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T15 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T15 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T15 · slightly warm
|
8 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T15 · neutral
|
5 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T15 · slightly cool
|
6 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T15 · cool
|
2 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T20 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T20 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T20 · slightly warm
|
7 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T20 · neutral
|
6 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T20 · slightly cool
|
7 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T20 · cool
|
1 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T25 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T25 · warm
|
1 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T25 · slightly warm
|
8 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T25 · neutral
|
6 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T25 · slightly cool
|
6 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T25 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T30 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T30 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T30 · slightly warm
|
8 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T30 · neutral
|
10 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T30 · slightly cool
|
2 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T30 · cool
|
1 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T35 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T35 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T35 · slightly warm
|
7 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T35 · slightly cool
|
5 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T35 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T40 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T40 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T40 · slightly warm
|
5 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T40 · neutral
|
13 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T40 · slightly cool
|
3 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T40 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T45 · slightly cool
|
2 Participants
|
|
Subjective Temperature Sensation
Methyl salicylate: T45 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel:BL · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel:BL · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel:BL · slightly warm
|
1 Participants
|
|
Subjective Temperature Sensation
Placebo gel:BL · neutral
|
18 Participants
|
|
Subjective Temperature Sensation
Placebo gel:BL · slightly cool
|
2 Participants
|
|
Subjective Temperature Sensation
Placebo gel:BL · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T0 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T0 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T0 · slightly warm
|
3 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T5 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T5 · slightly warm
|
4 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T5 · neutral
|
12 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T5 · slightly cool
|
5 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T5 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T10 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T10 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T10 · slightly warm
|
4 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T10 · neutral
|
12 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T10 · slightly cool
|
5 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T10 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T15 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T15 · warm
|
1 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T15 · slightly warm
|
3 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T15 · neutral
|
13 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T15 · slightly cool
|
4 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T15 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T20 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T20 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T20 · neutral
|
13 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T20 · slightly cool
|
4 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T20 · cool
|
1 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T25 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T25 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T25 · slightly warm
|
2 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T25 · neutral
|
17 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T25 · slightly cool
|
2 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T25 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T30 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T30 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T30 · slightly warm
|
2 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T30 · neutral
|
15 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T30 · slightly cool
|
4 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T35 · neutral
|
18 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T35 · slightly cool
|
1 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T35 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T40 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T40 · warm
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T40 · slightly cool
|
2 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T40 · cool
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T45 · hot
|
0 Participants
|
|
Subjective Temperature Sensation
Placebo gel: T45 · warm
|
0 Participants
|
PRIMARY outcome
Timeframe: At baseline and during 45 minutes post applicationPopulation: 21 participants received methyl salicylate gel on a 5 cm × 10 cm skin area on one side of the thoracic spine and placebo gel on the other side; the side was randomized.
Thermal comfort was assessed ("Do you find this. . .?") in each skin area according to the ISO 10551 standard using using a 5-point Likert scale with 0 = comfortable, 1 = slightly uncomfortable, 2 = uncomfortable, 3 = very uncomfortable, 4 = extremely uncomfortable.
Outcome measures
| Measure |
Healthy Women Receiving Topical Application of Methyl Salicylate and Placebo Gels
n=21 Participants
Healthy women participated. Two adjacent skin areas were marked on the thoracic spine (Th4-Th7). On one side, a methyl salicylate gel (Perskindol Dolo Gel-based formulation) was applied; on the other side, a placebo gel was applied.
Methyl salicylate gel composition: natural wintergreen oil (12.9%), hydroxyethyl cellulose (5%), water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol.
Placebo gel composition: hydroxyethyl cellulose, water, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol. The placebo gel differed only by the absence of natural wintergreen oil.
|
|---|---|
|
Subjective Thermal Comfort
Methyl salicylate: T5 · comfortable
|
11 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T5 · slightly uncomfortable
|
9 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T5 · uncomfortable
|
1 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T15 · slightly uncomfortable
|
3 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T15 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T20 · comfortable
|
20 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T20 · slightly uncomfortable
|
1 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T20 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T25 · comfortable
|
19 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T5 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T10 · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T15 · comfortable
|
20 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T15 · slightly uncomfortable
|
1 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T15 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T40 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T45 · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T45 · slightly uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T45 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: BL · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: BL · slightly uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: BL · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T0 · comfortable
|
18 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T0 · slightly uncomfortable
|
2 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T0 · uncomfortable
|
1 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T10 · comfortable
|
15 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T10 · slightly uncomfortable
|
6 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T10 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T15 · comfortable
|
18 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T25 · slightly uncomfortable
|
2 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T25 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T30 · comfortable
|
19 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T30 · slightly uncomfortable
|
2 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T30 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T35 · comfortable
|
19 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T35 · slightly uncomfortable
|
2 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T35 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T40 · comfortable
|
20 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T40 · slightly uncomfortable
|
1 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T40 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T45 · comfortable
|
19 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T45 · slightly uncomfortable
|
2 Participants
|
|
Subjective Thermal Comfort
Methyl salicylate: T45 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel:BL · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Placebo gel:BL · slightly uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel:BL · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T0 · comfortable
|
19 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T0 · slightly uncomfortable
|
2 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T0 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T5 · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T5 · slightly uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T10 · slightly uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T10 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T20 · comfortable
|
20 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T20 · slightly uncomfortable
|
1 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T20 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T25 · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T25 · slightly uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T25 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T30 · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T30 · slightly uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T30 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T35 · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T35 · slightly uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T35 · uncomfortable
|
0 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T40 · comfortable
|
21 Participants
|
|
Subjective Thermal Comfort
Placebo gel: T40 · slightly uncomfortable
|
0 Participants
|
Adverse Events
Methyl Salicylate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ron Clijsen
Rehabilitation and Exercise Science Laboratory (RESlab), University of Applied Sciences and Arts of Southern Switzerland
Phone: 0041 81 300 01 78
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place