Trial Outcomes & Findings for A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients (NCT NCT06357221)
NCT ID: NCT06357221
Last Updated: 2026-06-09
Results Overview
Body Surface Area is a measure of how much skin is impacted by psoriasis using the following measurement.7 One handprint is equal approximately to 1% of Body Surface Area. A decrease in scores indicated an improvement.
COMPLETED
PHASE4
46 participants
Baseline, Week 2, Week 4, Week 8
2026-06-09
Participant Flow
46 subjects met the inclusion and exclusion criteria, and were enrolled in the study.
Participant milestones
| Measure |
Skincare Product Treatment
Subjects applied the study products to the area of active lesion twice daily.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients
Baseline characteristics by cohort
| Measure |
Skincare Product Treatment
n=46 Participants
Subjects applied study products to the area of active lesions twice daily.
|
|---|---|
|
Age, Continuous
|
57.2 Years
STANDARD_DEVIATION 15.9 • n=20 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: Intention to treat population was used for primary outcome.
Body Surface Area is a measure of how much skin is impacted by psoriasis using the following measurement.7 One handprint is equal approximately to 1% of Body Surface Area. A decrease in scores indicated an improvement.
Outcome measures
| Measure |
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Change in Psoriatic Body Surface Area Compared to Baseline
Week 8
|
5.1 BSA %
Standard Deviation 5.55
|
|
Change in Psoriatic Body Surface Area Compared to Baseline
Baseline
|
9.3 BSA %
Standard Deviation 10.1
|
|
Change in Psoriatic Body Surface Area Compared to Baseline
Week 2
|
7.55 BSA %
Standard Deviation 6.89
|
|
Change in Psoriatic Body Surface Area Compared to Baseline
Week 4
|
7.49 BSA %
Standard Deviation 11.34
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: Intention to treat population is used for primary outcome.
Target lesion severity was measured by the Target Lesion Severity Score. Target Lesion Severity Score assessed erythema, induration, and scaling separately on a scale of 0-8, with 0 meaning no evidence of the parameter and 8 meaning very severe presence of the parameter. Target Lesion Severity Score was calculated as cumulative total of all 3 parameters, which a maximum score of 24 (8 x 3) and minimum score of 0. Total scale range is 0-24, where higher scores are worse outcomes. A decrease in scores indicated an improvement.
Outcome measures
| Measure |
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Change in Target Lesion Severity Compared to Baseline
Baseline
|
10.85 Score on a scale
Standard Deviation 3.67
|
|
Change in Target Lesion Severity Compared to Baseline
Week 2
|
7.24 Score on a scale
Standard Deviation 3.59
|
|
Change in Target Lesion Severity Compared to Baseline
Week 4
|
5.34 Score on a scale
Standard Deviation 4.07
|
|
Change in Target Lesion Severity Compared to Baseline
Week 8
|
3.51 Score on a scale
Standard Deviation 3
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: Intention to treat population was used for primary outcome.
Physician Global Assessment assessed overall severity of psoriasis on a scale of 0 to 5, with 0 meaning no presence of psoriasis and 5 meaning very severe presence of psoriasis. A decrease in scores indicated an improvement.
Outcome measures
| Measure |
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Change of Physician Global Assessment Compared to Baseline
Baseline
|
2.67 Score on a scale
Standard Deviation 0.7
|
|
Change of Physician Global Assessment Compared to Baseline
Week 2
|
2.36 Score on a scale
Standard Deviation 0.79
|
|
Change of Physician Global Assessment Compared to Baseline
Week 4
|
1.73 Score on a scale
Standard Deviation 0.87
|
|
Change of Physician Global Assessment Compared to Baseline
Week 8
|
1.37 Score on a scale
Standard Deviation 0.83
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: This outcome measure was only performed at one study site only; therefore, the number of participants was representative of the selected study site and less than the total study participant number. Intention to treat population was used for primary outcome.
Macroscopic imaging was performed using Visioscan® VC 20plus to take an image of the target lesion. The Visioscan software was used to calculate the analyze the images for skin scaliness (a decrease in values indicates an improvement in roughness).
Outcome measures
| Measure |
Skincare Product Treatment
n=20 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Change in Skin Scaliness Measured by Macroscopic Imaging
Week 4
|
5.52 Pixels
Standard Deviation 4.26
|
|
Change in Skin Scaliness Measured by Macroscopic Imaging
Baseline
|
10.77 Pixels
Standard Deviation 4.92
|
|
Change in Skin Scaliness Measured by Macroscopic Imaging
Week 2
|
6.78 Pixels
Standard Deviation 3.63
|
|
Change in Skin Scaliness Measured by Macroscopic Imaging
Week 8
|
5.71 Pixels
Standard Deviation 4.36
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: This outcome measure was only performed at one study site only; therefore, the number of participants was representative of the selected study site and less than the total study participant number. Intention to treat population was used for primary outcome.
Macroscopic imaging was performed using Visioscan® VC 20plus to take an image of the target lesion. The Visioscan software was used to calculate the analyze the images for skin smoothness (a decrease in values indicates an improvement in skin smoothness).
Outcome measures
| Measure |
Skincare Product Treatment
n=20 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Change in Skin Smoothness Measured by Macroscopic Imaging
Baseline
|
596.43 Pixels
Standard Deviation 192.39
|
|
Change in Skin Smoothness Measured by Macroscopic Imaging
Week 2
|
394.49 Pixels
Standard Deviation 169.99
|
|
Change in Skin Smoothness Measured by Macroscopic Imaging
Week 4
|
376.72 Pixels
Standard Deviation 205.51
|
|
Change in Skin Smoothness Measured by Macroscopic Imaging
Week 8
|
353.95 Pixels
Standard Deviation 192.12
|
PRIMARY outcome
Timeframe: Week 2Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated as appropriate. Number of participants with favorable responses was provided for each question.
Outcome measures
| Measure |
Skincare Product Treatment
n=42 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Subject Treatment Satisfaction
Subjects reported the cleanser left their skin feeling clean
|
39 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the cleanser didn't irritate their skin
|
38 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects report this cleanser didn't dry their skin out
|
40 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported their skin felt nourished after using the regimen
|
39 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported it was easy to incorporate this skincare regimen into daily prescription routine
|
40 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported this moisturizer had helped the lesions feel softer
|
40 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the skin lesions felt smoother since starting this moisturizer
|
36 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported their skin looked healthier since starting this moisturizer
|
33 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the moisturizer kept their skin feeling hydrated throughout the day
|
38 Participants with favorable responses
|
PRIMARY outcome
Timeframe: Week 4Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated and reported as appropriate. Number of participants with favorable responses was provided for each question.
Outcome measures
| Measure |
Skincare Product Treatment
n=41 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Subject Treatment Satisfaction
Subjects reported their skin was less dry and cracked
|
36 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported they worried less about their skin since starting the regimen
|
34 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the products worked well with their prescription treatment as a complete regimen
|
37 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported this moisturizer helped smooth out their skin's rough texture
|
39 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported their skin appeared healthier-looking since starting this moisturizer
|
38 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the skin lesions felt much softer since starting this moisturizer
|
39 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported this moisturizer had helped the lesions feel more hydrated
|
40 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the skin lesions looked less flaky since starting this moisturizer
|
39 Participants with favorable responses
|
PRIMARY outcome
Timeframe: Week 8Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated and reported as appropriate. Number of participants with favorable responses was provided for each question.
Outcome measures
| Measure |
Skincare Product Treatment
n=41 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Subject Treatment Satisfaction
Subjects reported they loved how soft their skin felt
|
39 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the cleanser was gentle for daily use on their psoriasis skin
|
41 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the skin felt the least irritated since starting this skincare regimen
|
34 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects report their skin hadn't felt this great in a long time
|
37 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported this was thei favorite skincare regimen
|
34 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported this skincare regimen was the perfect choice as part of prescription regimen
|
36 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported their skin was at the healthiest-looking state since using this moisturizer
|
37 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported this moisturizer helped sooth my sensitive skin
|
41 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported the skin lesions had been consistently hydrated since using this moisturizer
|
39 Participants with favorable responses
|
|
Subject Treatment Satisfaction
Subjects reported this moisturizer helped smoothen out the rough, scaly lesions
|
40 Participants with favorable responses
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: Intention to treat population was used for primary outcome.
Tolerability assessment was performed by the Investigator (parameter: dryness) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). Investigator graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.
Outcome measures
| Measure |
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Baseline
|
2.09 Score on a scale
Standard Deviation 0.72
|
|
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Week 2
|
1.38 Score on a scale
Standard Deviation 0.70
|
|
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Week 4
|
1.07 Score on a scale
Standard Deviation 0.98
|
|
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Week 8
|
0.71 Score on a scale
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: Intention to treat population was used for primary outcome.
Tolerability assessment was performed by subjects (parameters: burning/stinging) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). subjects graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.
Outcome measures
| Measure |
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Baseline
|
1.15 Score on a scale
Standard Deviation 1.05
|
|
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Week 2
|
0.67 Score on a scale
Standard Deviation 0.93
|
|
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Week 4
|
0.27 Score on a scale
Standard Deviation 0.67
|
|
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Week 8
|
0.12 Score on a scale
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: Intention to treat population was used for primary outcome.
Tolerability assessment was performed by subjects (parameters: itching) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). Subjects graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.
Outcome measures
| Measure |
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Change in Itching Compared to Baseline [Tolerability Assessment]
Baseline
|
2.04 Score on a scale
Standard Deviation 0.97
|
|
Change in Itching Compared to Baseline [Tolerability Assessment]
Week 2
|
0.98 Score on a scale
Standard Deviation 0.98
|
|
Change in Itching Compared to Baseline [Tolerability Assessment]
Week 4
|
0.68 Score on a scale
Standard Deviation 0.93
|
|
Change in Itching Compared to Baseline [Tolerability Assessment]
Week 8
|
0.29 Score on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Intention to treat population was used for secondary outcome.
Subjects were asked about their life quality by completing a Quality of Life questionnaire of 10 questions. Each question is scored from 0-3, with 0 being "not at all" or "not relevant" and 3 being "very much". All scores were summed to determine the Dermatology Quality of Life Index with score range 0-30: 0-1 (no effect at all on patient's life), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect), 21-30 (extremely large effect). A decrease in score totals from baseline to Week 8 indicated an improvement. A higher score indicates a greater impairment of quality of life.
Outcome measures
| Measure |
Skincare Product Treatment
n=46 Participants
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Subject Quality of Life Satisfaction
Baseline
|
9.24 Score on a scale
Standard Deviation 6.77
|
|
Subject Quality of Life Satisfaction
Week 8
|
2.85 Score on a scale
Standard Deviation 3.17
|
Adverse Events
Skincare Product Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Skincare Product Treatment
n=46 participants at risk
Subjects applied the study products to the area of active lesions twice daily.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Itchy
|
2.2%
1/46 • 8 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
|
|
Skin and subcutaneous tissue disorders
Burning/Stinging
|
6.5%
3/46 • 8 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place