Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne

NCT ID: NCT05446402

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-12-31

Brief Summary

The objective of this study is to compare tolerability of two similar commercially available over the counter acne regimens (Geologie and Proactiv) in individuals with mild to moderate acne vulgaris over a 12-week daily treatment course.

Detailed Description

Acne vulgaris is a common, chronic inflammatory skin disorder that originates in the pilosebaceous unit. Acne typically begins in adolescence and often continues into adulthood, with about 20% of cases resulting in scars or hyperpigmentation. It's estimated that acne affects about 85% of adolescents. Individuals who experience acne and acne scars tend to also experience a negative impact on their social and mental health, including depression, anxiety, and social withdrawal. Currently, topical solutions and lifestyle changes are the primary treatment for mild to moderate acne.

This study will evaluate and compare the efficacy of two over the counter products in treating individuals with mild to moderate acne: Geologie and ProActive. Both sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.

Conditions

Acne

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acne Treatment

Group Type: EXPERIMENTAL

Geologie Acne Regimen - one side of face

Intervention Type: COMBINATION_PRODUCT

Geologie is an over-the-counter cosmetic acne regimen with three products. The regimen also has three "levels" over the course of three months, in which the nighttime lotion is switched to a stronger formula each month. The Geologie Clear System regimen for acne prone skin includes:

1. Clarifying Gel Cleanser - SA Formula (2% Salicylic Acid)

2. Brightening Day Cream - SPF 15 (5% Azelaic Acid, 2% Hyaluronic Acid, 1%Niacinamide)

3. Repairing Night Cream -

1. Level 1 (0.05% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)

2. Level 2 (0.2% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)

3. Level 3 (0.3% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)

Proactive Acne Regimen - other side of face

Intervention Type: COMBINATION_PRODUCT

ProActiv is an over-the-counter cosmetic regimen with three products. The

Proactiv Solution 3-Piece System regimen includes:

1. Renewing Cleanser (Active ingredient: 2.5% Benzoyl Peroxide)

2. Revitalizing Toner (Glycolic Acid)

3. Repairing Treatment (Active ingredient: 2.5% Benzoyl Peroxide)

Interventions

Geologie Acne Regimen - one side of face

Geologie is an over-the-counter cosmetic acne regimen with three products. The regimen also has three "levels" over the course of three months, in which the nighttime lotion is switched to a stronger formula each month. The Geologie Clear System regimen for acne prone skin includes:

1. Clarifying Gel Cleanser - SA Formula (2% Salicylic Acid)

2. Brightening Day Cream - SPF 15 (5% Azelaic Acid, 2% Hyaluronic Acid, 1%Niacinamide)

3. Repairing Night Cream -

1. Level 1 (0.05% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)

2. Level 2 (0.2% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)

3. Level 3 (0.3% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)

Intervention Type: COMBINATION_PRODUCT

Proactive Acne Regimen - other side of face

ProActiv is an over-the-counter cosmetic regimen with three products. The

Proactiv Solution 3-Piece System regimen includes:

1. Renewing Cleanser (Active ingredient: 2.5% Benzoyl Peroxide)

2. Revitalizing Toner (Glycolic Acid)

3. Repairing Treatment (Active ingredient: 2.5% Benzoyl Peroxide)

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• No known active skin infection.
• Presence of mild or moderate acne on face (clinical diagnosis or self-report)
• Willingness to give written consent and comply with study procedures.

Exclusion Criteria

• Active skin infection.
• Inability to understand instructions or procedures involved.
• Known allergy to ingredient(s) in products being used for study.
• Pregnant women, prisoners, and vulnerable populations.
• Has a history of acute or chronic disease that may interfere with or increase the risk of study participation.
• Has any dermatological disorder that may interfere with the accurate evaluation of the subject's facial appearance, based on the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Rangel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Rangel

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU#00217056

Identifier Type: -

Identifier Source: org_study_id