Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.

NCT ID: NCT01909713

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-06-30

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.

Conditions

Acne Prone Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Facial Cleanser and Moisturizer SPF 30

All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.

Group Type: EXPERIMENTAL

Facial Cleanser and Moisturizer SPF 30

Intervention Type: DRUG

Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30

Interventions

Facial Cleanser and Moisturizer SPF 30

Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30

Intervention Type: DRUG

Other Intervention Names

Cetaphil® DermaControl™ skin care products

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Warren Winkelman, MD, MBA, PhD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

RCTS, Inc.

Irving, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25973678 (View on PubMed)

Other Identifiers

GLI.04.SRE.04.US10245

Identifier Type: -

Identifier Source: org_study_id