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

NCT05446402 | Completed Phase 4

• 1 other identifier: STU#00217056
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Acne Treatment

EXPERIMENTAL

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

Interventions

Geologie Acne Regimen - one side of face 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)

Acne Treatment

Proactive Acne Regimen - other side of face 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)

Acne Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Stephanie Rangel

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: All sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be using Product 1 regimen on left side of face for 12 weeks and Product 2 regimen on right side of face for 12 weeks.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: June 15, 2022
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)