A Clinical Investigation With Epaderm® Cream

NCT03738163 | Completed Results

• 1 other identifier: Epaderm01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

This investigation is designed as a prospective, non-randomised, single arm clinical investigation. Data is collected from approximately 120 evaluable subjects, divided into three groups of approximately 40 subjects; infants (0-36 months old), children (3-18 years old) and adults (\>18 years old), with the following indications: eczema, psoriasis and other dry skin conditions. Each subject will be followed during 4 weeks treatment, with a visit at baseline (visit 1), at 2 weeks (visit 2) and at 4 weeks (visit 3) treatment.

Conditions

Eczema; Psoriasis; Dry Skin; Eczema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improved Skin Moisturization

  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:

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

Secondary Outcomes (7)

• Number of Participants With Improved Skin Softness

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

• Number of Participants With Improved Overall Dry Skin/Xerosis

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

• Number of Participants Who Confirmed Overall Effect and Comfort of Treatment

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

• Number of Participants With Adverse Device Effects (ADEs)

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

• Number of Participants Who Reported Applying Epaderm Cream Twice a Day

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

Study Arms (1)

Epaderm Cream

OTHER

This is an open, non randomised single arm study.

Device: Epaderm Cream

Interventions

Epaderm Cream DEVICE

The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.

Epaderm Cream

Eligibility Criteria

• Age: 4 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects suitable for treatment with Epaderm Cream, as deemed by the investigator and according to intended use (eczema, psoriasis and other dry skin conditions).
• Subject or subject's legal representative must be able to read and sign the Patient Information and Consent Form.

You may not qualify if:

• Known allergy/hypersensitivity to any of the components of Epaderm Cream.
• Subject not suitable for the investigation according to the investigator's judgement.
• Subject participating in other ongoing similar clinical studies or other clinical studies which could interfere with this investigation, as judged by the investigator.
• Subject previously enrolled in the current clinical investigation.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

Poole Hospital NHS Foundation Trust

Poole, Dorset, BH15 2JB, United Kingdom

Location

Whiteladies Medical Group

Bristol, BS8 2 PU, United Kingdom

Location

MeSH Terms

Conditions

Eczema; Psoriasis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Results Point of Contact

• Title: Sabrina Chowdhury
• Organization: Mölnlycke Health Care

sabrina.chowdhury@molnlycke.com

+44 (0)7769 907654

Study Officials

• Suzannah August, MD

  Poole Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: infants (0-36 months old), children (3-18 years old) and adults (\>18 years old)

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 13, 2018
• Study Start: April 1, 2019
• Primary Completion: October 25, 2019
• Study Completion: June 17, 2020
• Last Updated: June 23, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-06

Locations

GB (2)