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

Derm Research

Status and phase: Completed; Phase 4

Conditions: Post Inflammatory Hyperpigmentation; Acne Vulgaris

Treatments: Drug: Azelaic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01038869

FIN0901

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Azelaic acid 15% (Finacea)

Experimental group

Description:

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

Treatment:

Drug: Azelaic acid