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COMPLETEDPHASE4

Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)

Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris

NCT01038869•Derm Research, PLLC

Summary

Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, at least 12 years of age
•Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
•Fitzpatrick skin type IV to VI
•Acne IGA (Investigator Global Assessment) score of 2 or 3
•Inflammatory lesions of 15-60 (with no more than 2 nodules)
•Non-inflammatory lesions of 20-100
•Post Inflammatory Hyperpigmentation Investigator Global Assessment (PIH IGA) score of 3,4 or 5
•Able to understand the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must have the written informed consent of a parent or legal guardian

Exclusion Criteria

•Female subjects who are pregnant, breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control
•Allergy or sensitivity to any component of the test medication
•Subjects who have not complied with the wash out periods for prohibited medications
•Medical condition that contraindicates participation
•Skin disease/disorder that might interfere with the diagnosis of acne vulgaris or PIH
•Evidence of recent alcohol or drug abuse
•History of poor cooperation, non-compliance or unreliability
•Exposure to an investigational drug study within 30 day of Baseline visit

Locations (1)

DermResearch, PLLC

Louisville, Kentucky, United States

Key Dates

Start Date

December 1, 2009

Primary Completion Date

April 1, 2010

Completion Date

May 1, 2010

Last Updated

September 25, 2012

Enrollment

ACTUAL participants

Conditions

Acne VulgarisPost Inflammatory Hyperpigmentation

Interventions

Azelaic acid

DRUG

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

NCT07205107

Acne Vulgaris

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RECRUITINGPHASE1/PHASE2

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

NCT05891795

Acne Vulgaris

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RECRUITINGNA

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)

Inclusion Criteria

Exclusion Criteria

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris

A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne