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

Double Blinded, Split Face Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Combination product: Geologie Acne Regimen - one side of face; Combination product: Proactive Acne Regimen - other side of face

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Acne Treatment

Combination product: 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: Clarifying Gel Cleanser - SA Formula (2% Salicylic Acid); Brightening Day Cream - SPF 15 (5% Azelaic Acid, 2% Hyaluronic Acid, 1%Niacinamide); Repairing Night Cream -Level 1 (0.05% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)Level 2 (0.2% Retinol, 3% Niacinamide, 2% Hyaluronic Acid)Level 3 (0.3% Retinol, 3% Niacinamide, 2% Hyaluronic Acid); 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: Renewing Cleanser (Active ingredient: 2.5% Benzoyl Peroxide); Revitalizing Toner (Glycolic Acid); Repairing Treatment (Active ingredient: 2.5% Benzoyl Peroxide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IGA Score between Geologie and ProActiv daily treatment	Investigator Global Assessment (IGA) will be collected on a scale of 0-4 with 0 being clear and 4 being severe.	12 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Stephanie Rangel, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: STU#00217056

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No