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

NCT ID: NCT01038869

Last Updated: 2012-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acne Vulgaris Post Inflammatory Hyperpigmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azelaic acid 15% (Finacea)

Open label pilot study, Topical gel to be appiled twice daily for 16 weeks

Group Type EXPERIMENTAL

Azelaic acid

Intervention Type DRUG

Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.

Interventions

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Azelaic acid

Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.

Intervention Type DRUG

Other Intervention Names

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Finacea

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Derm Research, PLLC

OTHER

Sponsor Role lead

Responsible Party

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Leon Kircik, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leon H. Kircik, M.D.

Role: PRINCIPAL_INVESTIGATOR

DermResearch, PLLC

Locations

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DermResearch, PLLC

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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FIN0901

Identifier Type: -

Identifier Source: org_study_id