A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
NCT ID: NCT02755545
Last Updated: 2023-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
127 participants
INTERVENTIONAL
2016-05-01
2017-04-04
Brief Summary
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Detailed Description
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2. 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
3. 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
4. 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Product A (adapalene)
Product A applied topically to the entire face or other affected area of the skin once daily
Product A
Product A applied topically to the entire face or other affected area of the skin once daily
Product B (salicylic acid)
Product B applied topically to the affected area of the skin 1 to 3 times daily.
Product B
Product B applied topically to affected area of the skin 1 to 3 times daily
Interventions
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Product A
Product A applied topically to the entire face or other affected area of the skin once daily
Product B
Product B applied topically to affected area of the skin 1 to 3 times daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Individuals with mild to moderate acne (score of 2-3 on FDA Investigator's Global Assessment Scale1) on the face.
3. Individuals with at least 5 inflammatory lesions.
4. Individuals with 10 - 100 non-inflammatory lesions.
5. Fitzpatrick skin type I-VI
6. 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.
7. Willing to withhold all facial treatments during the course of the study
8. Individuals of child bearing potential who use an acceptable method of contraception throughout the study.
9. Subjects must be stable on any medication they are taking for at least 30 days.
Exclusion Criteria
2. Individuals having a condition and/or disease of the skin that the Investigator deems inappropriate for participation.
3. Women who are nursing, pregnant, or planning to become pregnant during the study.
4. 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.
5. 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.
6. 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.
7. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study.
8. 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.
9. 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.
10. Individuals that are currently taking or have taken within the last 30 days oral or topical prescription medications for acne.
21 Years
45 Years
ALL
Yes
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Stephens & Associates, Inc. Texas Research Center
Richardson, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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GLI.04.SPR.US10354
Identifier Type: -
Identifier Source: org_study_id