Back to resultsTolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
Primary Purpose
Acne Prone Skin
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Facial Cleanser and Moisturizer SPF 30
Sponsored by
About this trial
This is an interventional treatment trial for Acne Prone Skin focused on measuring acne, pediatric
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
Sites / Locations
- RCTS, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Facial Cleanser and Moisturizer SPF 30
Arm Description
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.
Outcomes
Primary Outcome Measures
Cutaneous Tolerability Based on Visual Inspection - Erythema
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
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
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
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
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching
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
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
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
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)
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)
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01909713
Brief Title
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Prone Skin
Keywords
acne, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Facial Cleanser and Moisturizer SPF 30
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Facial Cleanser and Moisturizer SPF 30
Other Intervention Name(s)
Cetaphil® DermaControl™ skin care products
Intervention Description
Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30
Primary Outcome Measure Information:
Title
Cutaneous Tolerability Based on Visual Inspection - Erythema
Description
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.
Time Frame
Week 3
Title
Cutaneous Tolerability Based on Visual Inspection - Edema
Description
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.
Time Frame
Week 3
Title
Cutaneous Tolerability Based on Visual Inspection - Dryness
Description
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.
Time Frame
Week 3
Title
Cutaneous Tolerability Based on Visual Inspection - Roughness
Description
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.
Time Frame
Week 3
Secondary Outcome Measure Information:
Title
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching
Description
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
Time Frame
Week 3
Title
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning
Description
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
Time Frame
Week 3
Title
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging
Description
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
Time Frame
Week 3
Title
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness
Description
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
Time Frame
Week 3
Title
Barrier Function (TEWL)
Description
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.
Time Frame
Week 3
Title
Hydration (Corneometry)
Description
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."
Time Frame
Week 3
Title
Subject Satisfaction Questionnaire - Face Wash
Description
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).
Time Frame
Day 22
Title
Subject Satisfaction Questionnaire - Moisturizer
Description
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).
Time Frame
Day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Winkelman, MD, MBA, PhD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
RCTS, Inc.
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25973678
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.
Results Reference
derived
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Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
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