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

Phase 4

Completed

• Conditions: Acne
• Interventions: Combination Product: Geologie Acne Regimen - one side of face; Combination Product: Proactive Acne Regimen - other side of face

• Registration Number: NCT05446402
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Primary Completion: 2023-05-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acne Treatment	Geologie Acne Regimen - one side of face	-
Acne Treatment	Proactive Acne Regimen - other side of face	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States