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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446402
• Other study ID #: STU#00217056
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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