Clinical trial NCT01909713: Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
Official title: Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Prone Skin
Keywords: acne, pediatric
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This was a open-label, single center study conducted in the United States that evaluated the tolerability of Cetaphil® DermaControl™ skin care products used at least once daily for 22 days in male and female subjects age 7 to 11 with acne prone skin. There were 4 visits during the course of the study: screening (within 7 days of visit 1), visit 1(baseline /day1), visit 2 (day 8), and visit 3 (day 22/exit). Tolerability assessments were performed by a board certified dermatologist at all visits. Subjects completed the baseline skin care regimen questionnaire at visit 1. Hydration assessments were competed at visits 1, 2, and 3. A subject satisfaction questionnaire was completed at visit 3. Adverse event assessments were conducted for all subjects at every clinic visit after informed consent/assent was signed.

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

Primary outcomes:
measure: Cutaneous Tolerability Based on Visual Inspection - Erythema
timeFrame: Week 3
measure: Cutaneous Tolerability Based on Visual Inspection - Edema
timeFrame: Week 3
measure: Cutaneous Tolerability Based on Visual Inspection - Dryness
timeFrame: Week 3
measure: Cutaneous Tolerability Based on Visual Inspection - Roughness
timeFrame: Week 3
Secondary outcomes:
measure: Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching
timeFrame: Week 3
measure: Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning
timeFrame: Week 3
measure: Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging
timeFrame: Week 3
measure: Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness
timeFrame: Week 3
measure: Barrier Function (TEWL)
timeFrame: Week 3
measure: Hydration (Corneometry)
timeFrame: Week 3
measure: Subject Satisfaction Questionnaire - Face Wash
timeFrame: Day 22
measure: Subject Satisfaction Questionnaire - Moisturizer
timeFrame: Day 22
Other outcomes:
Locations:
city: Irving
country: United States
facility: RCTS, Inc.
state: Texas
Study officials:
affiliation: Galderma R&D
name: Warren Winkelman, MD, MBA, PhD
role: STUDY_DIRECTOR
References:
citation: Hensley D, Meckfessel MH. Tolerability of a Skin Care Regimen Formulated for Acne-Prone Skin in Children. Pediatr Dermatol. 2015 Jul-Aug;32(4):501-5. doi: 10.1111/pde.12607. Epub 2015 May 14.