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Completed

NCT Number: NCT05446402

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • 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

Combination Product

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 outcomes

  1. Change in IGA Score between Geologie and ProActiv daily treatment

    Time frame: 12 weeks

    Investigator Global Assessment (IGA) will be collected on a scale of 0-4 with 0 being clear and 4 being severe.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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