A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments

A Multi-Center Clinical Trial to Evaluate the Efficacy of Two Acne Treatments

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: Product A; Drug: Product B

Detailed Description

1. 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
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

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • Stephens & Associates, Inc. Texas Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. Men and women age 21 to 45 years at the time of enrollment.
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.

Key Exclusion Criteria:

1. Individuals diagnosed with allergies to topical acne products.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Product A (adapalene); Product A applied topically to the entire face or other affected area of the skin once daily	Drug: Product A; Product A applied topically to the entire face or other affected area of the skin once daily; Other Names: Adapalene
Active Comparator: Product B (salicylic acid); Product B applied topically to the affected area of the skin 1 to 3 times daily.	Drug: Product B; Product B applied topically to affected area of the skin 1 to 3 times daily; Other Names: Salicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 1, Week 2, Week 6, Week 12, Week 18, Week 24
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.	Week 1, Week 2, Week 6, Week 12, Week 18, Week 24
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).	Week 1, Week 2, Week 6, Week 12, Week 18, Week 24
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)	Week 6, Week 12, Week 24
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)	Week 6, Week 12, Week 24
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)	Week 6, Week 12, Week 24
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)	Week 6, Week 12, Week 24
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).	Week 1, Week 2, Week 6, Week 12, Week 24
Incidence of Adverse Events		24 weeks
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).	Baseline, Week 1, Week 2, Week 6, Week 12, Week 24
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).	Baseline, Week 1, Week 2, Week 6, Week 12, Week 24
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).	Baseline, Week 1, Week 2, Week 6, Week 12, Week 24
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).	Baseline, Week 1, Week 2, Week 6, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Chair: Karen Hernandez, BS, Galderma Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): April 4, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimated): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid; Salicylates; Adapalene
• Other Study ID Numbers: GLI.04.SPR.US10354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO