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

Primary Purpose

Acne

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Geologie Acne Regimen - one side of face
Proactive Acne Regimen - other side of face
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acne Treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2022
Last Updated
July 24, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05446402
Brief Title
Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
Official Title
Double Blinded, Split Face Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
All sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acne Treatment
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Geologie Acne Regimen - one side of face
Intervention Description
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)
Intervention Type
Combination Product
Intervention Name(s)
Proactive Acne Regimen - other side of face
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in IGA Score between Geologie and ProActiv daily treatment
Description
Investigator Global Assessment (IGA) will be collected on a scale of 0-4 with 0 being clear and 4 being severe.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Rangel
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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