A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments

NCT02755545 | Completed Phase 4 Results

• 1 other identifier: GLI.04.SPR.US10354
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Total Lesions at Week 12

  Percent change from baseline in total lesions at week 12 was assessed by investigator or designee. Investigator or designee counted and recorded the number of open comedones, closed comedones, papules, and pustules on each subject's face. Lesions were counted globally on the following facial locations/quadrants: forehead, left cheek, chin, and right cheek. Each of the following lesion types were analyzed separately for forehead, left cheek, chin, right cheek, and the total of the 4 areas: * Inflammatory acne lesions (sum of papules and pustules) * Non-inflammatory acne lesions (sum of open comedones and closed comedones) * Total lesion counts (sum of inflammatory and non-inflammatory acne lesions counts)

  Baseline and 12 weeks

Study Arms (2)

Product A (adapalene)

ACTIVE COMPARATOR

Product A applied topically to the entire face or other affected area of the skin once daily

Drug: Product A

Product B (salicylic acid)

ACTIVE COMPARATOR

Product B applied topically to the affected area of the skin 1 to 3 times daily.

Drug: Product B

Interventions

Product A DRUG

Product A applied topically to the entire face or other affected area of the skin once daily

Also known as: Adapalene

Product A (adapalene)

Product B DRUG

Product B applied topically to affected area of the skin 1 to 3 times daily

Also known as: Salicylic acid

Product B (salicylic acid)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Stephens & Associates, Inc. Texas Research Center

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Salicylic Acid

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Hydroxy Acids; Benzene Derivatives; Phenols

Results Point of Contact

• Title: Director, Medical Affairs and Clinical Development
• Organization: Galderma

matthew.meckfessel@galderma.com

8179615325

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2016
• Primary Completion: April 4, 2017
• Study Completion: April 4, 2017
• Last Updated: December 28, 2023
• Results First Posted: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)