Trial Outcomes & Findings for A Clinical Investigation With Epaderm® Cream (NCT NCT03738163)

Results Overview

Participants were considered to have improved moisturization if they responded strongly agree or agree on the questionnaire. Evaluations were carried out in the same affected spot from a scale of Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree where Strongly agree is the most improved skin moisturization:

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

121 participants

Primary outcome timeframe

Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

Results posted on

2021-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Epaderm Cream This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Overall Study STARTED	121
Overall Study COMPLETED	114
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

7 subjects withdrew from the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epaderm Cream n=121 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Age, Continuous	30.5 years n=121 Participants
Sex: Female, Male Female	51 Participants n=114 Participants • 7 subjects withdrew from the study.
Sex: Female, Male Male	63 Participants n=114 Participants • 7 subjects withdrew from the study.
Region of Enrollment United Kingdom	121 participants n=121 Participants
Age, Categorical <=18 years	36 Participants n=121 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=121 Participants
Age, Categorical >=65 years	41 Participants n=121 Participants

PRIMARY outcome

Timeframe: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

Participants were considered to have improved moisturization if they responded strongly agree or agree on the questionnaire. Evaluations were carried out in the same affected spot from a scale of Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree where Strongly agree is the most improved skin moisturization:

Outcome measures

Outcome measures
Measure	Epaderm Cream n=121 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Number of Participants With Improved Skin Moisturization	114 Participants

SECONDARY outcome

Timeframe: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

Participants were considered to have improved softness if they responded strongly agree or agree on the questionnaire. Evaluations were carried out in the same affected spot from a scale of Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree where Strongly agree is the most improved skin softness.

Outcome measures

Outcome measures
Measure	Epaderm Cream n=114 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Number of Participants With Improved Skin Softness	82 Participants

SECONDARY outcome

Timeframe: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

Participants were considered to have improved overall dry skin if they responded 'absent' or 'faint scaling' on the questionnaire. Evaluations were carried out in the same affected spot from a scale of 0= Absent, 1= Faint scaling, faint roughness and dull appearance, 2= Small scales in combination with a few larger scales, slight roughness, whitish appearance, 3= Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4= Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks where 'absent' or 'fanit scaling' refers to improved overall dry skin.

Outcome measures

Outcome measures
Measure	Epaderm Cream n=114 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Number of Participants With Improved Overall Dry Skin/Xerosis	100 Participants

SECONDARY outcome

Timeframe: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

Participants confirmed the comfort during treatment from a scale of Very Poor, Poor, Average, Good and Excellent where Excellent is considered the most comforting during treatment.

Outcome measures

Outcome measures
Measure	Epaderm Cream n=114 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Number of Participants Who Confirmed Overall Effect and Comfort of Treatment	101 participants

SECONDARY outcome

Timeframe: Evaluated at every follow-up visit (2 weeks and 4 weeks visit)

Number of Adverse Device Effects (ADEs) related to the use of Epaderm Cream during the investigation.

Outcome measures

Outcome measures
Measure	Epaderm Cream n=114 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Number of Participants With Adverse Device Effects (ADEs)	10 Participants

SECONDARY outcome

Timeframe: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported

Frequency of Epaderm Cream application. Participants were asked how often Epaderm Cream was applied either once a day, twice a day, three times a day or four times a day with twice a day application being the most frequent.

Outcome measures

Outcome measures
Measure	Epaderm Cream n=114 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Number of Participants Who Reported Applying Epaderm Cream Twice a Day	67 Participants

SECONDARY outcome

Timeframe: Assessed at 2 weeks and 4 weeks visit. Improvement within 4 weeks visit reported.

Participants confirmed the time to visualize improvement of skin moisturization from the range immediately, within 2 weeks or not at all where immediately refers to the most increased improvements seen.

Outcome measures

Outcome measures
Measure	Epaderm Cream n=114 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Number of Participants With Improvement of Skin Moisturization By Week 4	107 Participants

SECONDARY outcome

Timeframe: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported where participates answered 'yes'.

Participants were asked to confirm if the product was used as a skin cleanser by answering yes or no where yes confirmed use of Epaderm cream as a skin cleanser.

Outcome measures

Outcome measures
Measure	Epaderm Cream n=114 Participants This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Number of Participants Who Used Epaderm as a Skin Cleanser	75 Participants

Adverse Events

Epaderm Cream

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Epaderm Cream n=121 participants at risk This is an open, non randomised single arm study. Epaderm Cream: The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
Skin and subcutaneous tissue disorders Flare of eczema	1.7% 2/121 • Number of events 2 • Adverse event data was collected over a period of 4 weeks from the baseline visit to the final follow-up visit.
Skin and subcutaneous tissue disorders Intermittent rash	3.3% 4/121 • Number of events 4 • Adverse event data was collected over a period of 4 weeks from the baseline visit to the final follow-up visit.
Skin and subcutaneous tissue disorders Inflammatory reaction	1.7% 2/121 • Number of events 2 • Adverse event data was collected over a period of 4 weeks from the baseline visit to the final follow-up visit.
Skin and subcutaneous tissue disorders Worsening of the skin	1.7% 2/121 • Number of events 2 • Adverse event data was collected over a period of 4 weeks from the baseline visit to the final follow-up visit.

Additional Information

Sabrina Chowdhury

Mölnlycke Health Care

Phone: +44 (0)7769 907654

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place