N/A
Completed N=121
A Clinical Investigation With Epaderm® Cream
Atopic Dermatitis · Psoriasis · Dry Skin; Eczema
Source: ClinicalTrials.gov NCT03738163 ↗
Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants With Improved Skin Moisturization — 114 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improved Skin Moisturization |
114 | — |
| SECONDARY Number of Participants With Improved Skin Softness |
82 | — |
| SECONDARY Number of Participants With Improved Overall Dry Skin/Xerosis |
100 | — |
| SECONDARY Number of Participants Who Confirmed Overall Effect and Comfort of Treatment |
101 | — |
| SECONDARY Number of Participants With Adverse Device Effects (ADEs) |
10 | — |
| SECONDARY Number of Participants Who Reported Applying Epaderm Cream Twice a Day |
67 | — |
| SECONDARY Number of Participants With Improvement of Skin Moisturization By Week 4 |
107 | — |
| SECONDARY Number of Participants Who Used Epaderm as a Skin Cleanser |
75 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03738163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.