Phase 4
N=35
Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
Acne Prone Skin
Bottom Line
View on ClinicalTrials.gov: NCT01909713 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Cutaneous Tolerability Based on Visual Inspection - Erythema — 29; 33; 30; 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Facial Cleanser and Moisturizer SPF 30 (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cutaneous Tolerability Based on Visual Inspection - Erythema |
29; 33; 30; 29; 6; 2 | — |
| PRIMARY Cutaneous Tolerability Based on Visual Inspection - Edema |
35; 35; 34; 34; 0; 0 | — |
| PRIMARY Cutaneous Tolerability Based on Visual Inspection - Dryness |
34; 33; 32; 32; 1; 2 | — |
| PRIMARY Cutaneous Tolerability Based on Visual Inspection - Roughness |
35; 34; 35; 34; 0; 1 | — |
| SECONDARY Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching |
33; 31; 34; 30; 2; 4 | — |
| SECONDARY Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning |
35; 33; 33; 31; 0; 2 | — |
| SECONDARY Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging |
35; 34; 35; 34; 0; 1 | — |
| SECONDARY Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness |
35; 35; 35; 35; 0; 0 | — |
| SECONDARY Barrier Function (TEWL) |
8.89; 11.41; 11.29 | — |
| SECONDARY Hydration (Corneometry) |
55.75; 56.51; 48.28 | — |
| SECONDARY Subject Satisfaction Questionnaire - Face Wash |
34; 35; 35; 32; 30; 6 | — |
| SECONDARY Subject Satisfaction Questionnaire - Moisturizer |
34; 28; 35; 33; 30; 4 | — |
Summary
The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects 7-11 years of age
- Subjects with acne-prone skin [Global severity of acne (GSA) Score of 1 (almost clear) or 2 (mild) and any oiliness evaluation score or GSA Score of 0 (none) with an oiliness evaluation score greater than or equal to 1 (mild)]
Exclusion Criteria
- Subjects with any visible skin condition or facial hair that could interfere with the evaluations
- Subjects taking other medications, supplements, or non-prescription treatments that, in the opinion of the principal investigator/board certified dermatologist, could interfere with the test results including any regimen of steroidal/non steroidal anti-inflammatory drugs or antihistamines
- Subjects currently under the treatment for asthma or diabetes (insulin-dependent only)
- Subjects with abnormal pigmented vascular skin lesions, abnormal skin pigmentation, or body art (tattoos, permanent or temporary) on the face, which could interfere with subsequent evaluations of dermal responsiveness
Data sourced from ClinicalTrials.gov (NCT01909713). 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.