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Trial record 6 of 339 for:    acne AND facial

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

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ClinicalTrials.gov Identifier: NCT01909713
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE July 1, 2013
First Posted Date  ICMJE July 26, 2013
Results First Submitted Date  ICMJE December 17, 2013
Results First Posted Date  ICMJE March 24, 2014
Last Update Posted Date March 24, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
Cutaneous Tolerability Based on Visual Inspection [ Time Frame: Week 3 ]
Cutaneous tolerability based on visual inspection [investigator reported severity scales - erythema (5 point), dryness (4 point), roughness (4 point), edema (4 point)] was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22)
Change History Complete list of historical versions of study NCT01909713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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."
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
  • Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview [ Time Frame: Week 3 ]
    Cutaneous tolerability based on subject and parent/legally authorized representative interview (investigator reported 4 point severity scale for itching, burning, stinging, and tightness) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22)
  • 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)
  • Hydration (Corneometry) [ Time Frame: Week 3 ]
    Hyrdation was assessed using corneometry at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
Official Title  ICMJE Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Prone Skin
Intervention  ICMJE Drug: Facial Cleanser and Moisturizer SPF 30
Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30
Other Name: Cetaphil® DermaControl™ skin care products
Study Arms  ICMJE 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.
Intervention: Drug: Facial Cleanser and Moisturizer SPF 30
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2013)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01909713
Other Study ID Numbers  ICMJE GLI.04.SRE.04.US10245
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Warren Winkelman, MD, MBA, PhD Galderma Laboratories, L.P.
PRS Account Galderma Laboratories, L.P.
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP