Status:

COMPLETED

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

Lead Sponsor:

Galderma R&D

Conditions:

Acne Prone Skin

Eligibility:

All Genders

7-11 years

Phase:

PHASE4

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT01909713

Start Date

May 1 2013

End Date

June 1 2013

Last Update

August 23 2022

Active Locations (1)

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1

RCTS, Inc.

Irving, Texas, United States, 75062