Back to resultsA Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
Primary Purpose
Acne
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Product A (adapalene)
Product B (salicylic acid)
Sponsored by
About this trial
This is an interventional treatment trial for Acne
Eligibility Criteria
Key Inclusion Criteria:
- Men and women age 21 to 45 years at the time of enrollment.
- Individuals with mild to moderate acne (score of 2-3 on FDA Investigator's Global Assessment Scale1) on the face.
- Individuals with at least 5 inflammatory lesions.
- Individuals with 10 - 100 non-inflammatory lesions.
- Fitzpatrick skin type I-VI
- Individuals willing to provide written informed consent including photo release, Health Insurance Portability and Accountability Act (HIPAA), and are able to read, speak,write, understand English.
- Willing to withhold all facial treatments during the course of the study
- Individuals of child bearing potential who use an acceptable method of contraception throughout the study.
- Subjects must be stable on any medication they are taking for at least 30 days.
Key Exclusion Criteria:
- Individuals diagnosed with allergies to topical acne products.
- Individuals having a condition and/or disease of the skin that the Investigator deems inappropriate for participation.
- Women who are nursing, pregnant, or planning to become pregnant during the study.
- Individuals who have pre-existing or dormant dermatologic conditions on the face which in the opinion of the Investigator could interfere with the outcome of the study.
- Individuals using or who have used any systemic medication considered to affect the course of acne, specifically, but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study.
- Individuals who are currently participating in another facial usage study or have participated in a clinical trial within 4 weeks prior to inclusion into the study.
- Individuals with any planned surgeries and/or invasive medical procedures during the course of the study.
- Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- Individuals with facial sunburn or excessive tanned facial skin or that are not willing to avoid daily sun exposure on the face and the use of tanning beds or sunless tanning products for the duration of the study.
- Individuals that are currently taking or have taken within the last 30 days oral or topical prescription medications for acne.
Sites / Locations
- Stephens & Associates, Inc. Texas Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Product A (adapalene)
Product B (salicylic acid)
Arm Description
Product A applied topically to the entire face or other affected area of the skin once daily
Product B applied topically to the affected area of the skin 1 to 3 times daily.
Outcomes
Primary Outcome Measures
Percent change in total lesions at Week 12 from baseline
Percent change from baseline assessment at week 12 as assessed by investigator or designee.
Secondary Outcome Measures
Mean change in inflammatory lesion count
Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee.
Note that papules and pustules are classified as inflammatory acne lesions.
Mean change in non-inflammatory lesion count
Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee.
Note that open and closed comedones are classified as non-inflammatory acne lesions.
Mean Change in Investigator's Global Assessment (IGA)
Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee using the IGA scale (0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe).
Mean change in skin texture (digital images)
Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):
0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)
Mean change in skin tone evenness (digital images)
Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):
0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)
Mean change in skin clarity (digital images)
Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):
0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)
Mean change in overall skin complexion (digital images)
Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):
0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)
Subject self-assessment questionnaire
Subjects will be asked to complete a self-assessment questionnaire at Week 1, Week 2, Week 6, Week 12, and Week 24. This questionnaire has a 5-point Likert Response Scale (1=Strongly Agree; 5=Strongly Disagree).
Incidence of Adverse Events
Mean change in erythema (tolerance) parameter
Investigator-reported erythema evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).
Mean change in dryness (tolerance) parameter
Investigator-reported dryness evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).
Mean change in scaling (tolerance) parameter
Investigator-reported scaling evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).
Mean change in stinging/burning (tolerance) parameter
Subject-reported stinging/burning evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02755545
Brief Title
A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
Official Title
A Multi-Center Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
April 4, 2017 (Actual)
Study Completion Date
April 4, 2017 (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 evaluate the efficacy of 2 acne treatments for 24 weeks of use in adult men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 - 100 non-inflammatory lesions.
Objective:
To characterize the effectiveness of the acne treatment in lesion count at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
To characterize the effectiveness of the acne treatment in Investigator's Global Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
To characterize the effect of the acne treatment in clinical grading of efficacy parameters through digital images at week 6, week 12, and week 24 as compared to baseline and compare between treatments
To characterize the effect of the acne treatment in subject self-assessment questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Product A (adapalene)
Arm Type
Active Comparator
Arm Description
Product A applied topically to the entire face or other affected area of the skin once daily
Arm Title
Product B (salicylic acid)
Arm Type
Active Comparator
Arm Description
Product B applied topically to the affected area of the skin 1 to 3 times daily.
Intervention Type
Drug
Intervention Name(s)
Product A (adapalene)
Intervention Description
Product A applied topically to the entire face or other affected area of the skin once daily
Intervention Type
Drug
Intervention Name(s)
Product B (salicylic acid)
Intervention Description
Product B applied topically to affected area of the skin 1 to 3 times daily
Primary Outcome Measure Information:
Title
Percent change in total lesions at Week 12 from baseline
Description
Percent change from baseline assessment at week 12 as assessed by investigator or designee.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean change in inflammatory lesion count
Description
Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee.
Note that papules and pustules are classified as inflammatory acne lesions.
Time Frame
Week 1, Week 2, Week 6, Week 12, Week 18, Week 24
Title
Mean change in non-inflammatory lesion count
Description
Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee.
Note that open and closed comedones are classified as non-inflammatory acne lesions.
Time Frame
Week 1, Week 2, Week 6, Week 12, Week 18, Week 24
Title
Mean Change in Investigator's Global Assessment (IGA)
Description
Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee using the IGA scale (0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe).
Time Frame
Week 1, Week 2, Week 6, Week 12, Week 18, Week 24
Title
Mean change in skin texture (digital images)
Description
Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):
0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)
Time Frame
Week 6, Week 12, Week 24
Title
Mean change in skin tone evenness (digital images)
Description
Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):
0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)
Time Frame
Week 6, Week 12, Week 24
Title
Mean change in skin clarity (digital images)
Description
Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):
0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)
Time Frame
Week 6, Week 12, Week 24
Title
Mean change in overall skin complexion (digital images)
Description
Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):
0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)
Time Frame
Week 6, Week 12, Week 24
Title
Subject self-assessment questionnaire
Description
Subjects will be asked to complete a self-assessment questionnaire at Week 1, Week 2, Week 6, Week 12, and Week 24. This questionnaire has a 5-point Likert Response Scale (1=Strongly Agree; 5=Strongly Disagree).
Time Frame
Week 1, Week 2, Week 6, Week 12, Week 24
Title
Incidence of Adverse Events
Time Frame
24 weeks
Title
Mean change in erythema (tolerance) parameter
Description
Investigator-reported erythema evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).
Time Frame
Baseline, Week 1, Week 2, Week 6, Week 12, Week 24
Title
Mean change in dryness (tolerance) parameter
Description
Investigator-reported dryness evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).
Time Frame
Baseline, Week 1, Week 2, Week 6, Week 12, Week 24
Title
Mean change in scaling (tolerance) parameter
Description
Investigator-reported scaling evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).
Time Frame
Baseline, Week 1, Week 2, Week 6, Week 12, Week 24
Title
Mean change in stinging/burning (tolerance) parameter
Description
Subject-reported stinging/burning evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).
Time Frame
Baseline, Week 1, Week 2, Week 6, Week 12, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Men and women age 21 to 45 years at the time of enrollment.
Individuals with mild to moderate acne (score of 2-3 on FDA Investigator's Global Assessment Scale1) on the face.
Individuals with at least 5 inflammatory lesions.
Individuals with 10 - 100 non-inflammatory lesions.
Fitzpatrick skin type I-VI
Individuals willing to provide written informed consent including photo release, Health Insurance Portability and Accountability Act (HIPAA), and are able to read, speak,write, understand English.
Willing to withhold all facial treatments during the course of the study
Individuals of child bearing potential who use an acceptable method of contraception throughout the study.
Subjects must be stable on any medication they are taking for at least 30 days.
Key Exclusion Criteria:
Individuals diagnosed with allergies to topical acne products.
Individuals having a condition and/or disease of the skin that the Investigator deems inappropriate for participation.
Women who are nursing, pregnant, or planning to become pregnant during the study.
Individuals who have pre-existing or dormant dermatologic conditions on the face which in the opinion of the Investigator could interfere with the outcome of the study.
Individuals using or who have used any systemic medication considered to affect the course of acne, specifically, but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study.
Individuals who are currently participating in another facial usage study or have participated in a clinical trial within 4 weeks prior to inclusion into the study.
Individuals with any planned surgeries and/or invasive medical procedures during the course of the study.
Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
Individuals with facial sunburn or excessive tanned facial skin or that are not willing to avoid daily sun exposure on the face and the use of tanning beds or sunless tanning products for the duration of the study.
Individuals that are currently taking or have taken within the last 30 days oral or topical prescription medications for acne.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Hernandez, BS
Organizational Affiliation
Galderma Laboratories
Official's Role
Study Chair
Facility Information:
Facility Name
Stephens & Associates, Inc. Texas Research Center
City
Richardson
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
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