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

Information source: Derm Research, PLLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris; Post Inflammatory Hyperpigmentation

Intervention: Azelaic acid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Derm Research, PLLC

Official(s) and/or principal investigator(s):
Leon H. Kircik, M.D., Principal Investigator, Affiliation: DermResearch, PLLC


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)

Secondary outcome:

Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)

Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution

Percentage Change in Total Lesion Counts

Tolerability Assessments as Measured by the Number of Participants With Side Effects


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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 and Contacts

DermResearch, PLLC, Louisville, Kentucky 40217, United States
Additional Information

Starting date: December 2009
Last updated: August 24, 2012

Page last updated: August 20, 2015

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