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

• ClinicalTrials.gov Identifier: NCT01909713
• Recruitment Status: Completed
• First Posted: July 26, 2013
• Results First Posted: March 24, 2014
• Last Update Posted: August 23, 2022
• Sponsor: Galderma R&D
• Information provided by (Responsible Party): Galderma R&D

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Prone Skin	Drug: Facial Cleanser and Moisturizer SPF 30	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
• Study Start Date: May 2013
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Facial Cleanser and Moisturizer SPF 30; Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30; Other Name: Cetaphil® DermaControl™ skin care products

Outcome Measures

Primary Outcome Measures :

1. Cutaneous Tolerability Based on Visual Inspection - Erythema [ Time Frame: Week 3 ]
   Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Erythema: 0 = none, no observable redness; 1 = very mild, slight redness, spotty or diffuse; 2 = mild, moderate redness; 3 = moderate, intense; 4 = severe, fiery red with edema.
2. Cutaneous Tolerability Based on Visual Inspection - Edema [ Time Frame: Week 3 ]
   Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Edema: 0 = none; 1 = mild; 2 = moderate; 3 = intense.
3. Cutaneous Tolerability Based on Visual Inspection - Dryness [ Time Frame: Week 3 ]
   Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Dryness: 0 = no observable scaling; 1 = fine flakes/scaling; 2 = moderate flakes/scaling; 3 = larger flakes/severe scaling.
4. Cutaneous Tolerability Based on Visual Inspection - Roughness [ Time Frame: Week 3 ]
   Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Roughness: 1 - no roughness, skin is fine, silky smooth, 2 - firm (not too rough, not too smooth), 3 - coarse, rough skin, 4 - leathery, flaky skin.

Secondary Outcome Measures :

1. Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching [ Time Frame: Week 3 ]
   Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Itching: 0 = none, no itching; 1 = mild, slight itching, not really bothersome; 2 = moderate, definite itching that is somewhat bothersome; 3 = severe, intense itching that may interrupt daily activities and/or sleep
2. Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning [ Time Frame: Week 3 ]
   Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Burning: 0 = none, no burning; 1 = mild, slight burning sensation, not really bothersome; 2 = moderate, definite warm, burning sensation that is somewhat bothersome; 3 = severe, hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep
3. Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging [ Time Frame: Week 3 ]
   Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Stinging: 0 = none, no stinging; 1 = mild, slight stinging sensation, not really bothersome; 2 = moderate, definite stinging sensation that is somewhat bothersome; 3 = severe, stinging sensation that causes definite discomfort and may interrupt daily activities and/or sleep
4. Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness [ Time Frame: Week 3 ]
   Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Tightness: 0 = none, no tightness; 1 = mild, slight tightness, not really bothersome; 2 = moderate, definite tightness sensation that is somewhat bothersome; 3 = severe, tightness sensation that causes definite discomfort and may interrupt daily activities and/or sleep
5. Barrier Function (TEWL) [ Time Frame: Week 3 ]
   Barrier function was assessed by measuring transepidermal water loss (TEWL) at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). TEWL measures water loss through the epidermis (for example, by evaporation). Measuring TEWL is a well-established way to assess the skin's water-barrier function. High TEWL values indicate impaired skin barrier function; low values indicate normal barrier function.
6. Hydration (Corneometry) [ Time Frame: Week 3 ]
   Hydration was assessed using corneometry at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Corneometry measures the hydration status of the skin. An increase in corneometry values indicates an increase in the hydration status of the skin, and vice versa. The test is procedure specific, so results are reported in "arbitrary units."
7. Subject Satisfaction Questionnaire - Face Wash [ Time Frame: Day 22 ]
   All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
8. Subject Satisfaction Questionnaire - Moisturizer [ Time Frame: Day 22 ]
   All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Texas

RCTS, Inc.

Irving, Texas, United States, 75062

Sponsors and Collaborators

Galderma R&D

Investigators

• Study Director: Warren Winkelman, MD, MBA, PhD; Galderma R&D

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01909713
• Other Study ID Numbers: GLI.04.SRE.04.US10245
• First Posted: July 26, 2013
• Results First Posted: March 24, 2014
• Last Update Posted: August 23, 2022
• Last Verified: December 2013

Keywords provided by Galderma R&D:

acne, pediatric

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases