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

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Azelaic acid 15% (Finacea)	Azelaic acid	Open label pilot study, Topical gel to be appiled twice daily for 16 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)	Baseline to 16 weeks	IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)	Baseline to16 weeks	IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement
Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution	Baseline to 16 weeks	The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%
Percentage Change in Total Lesion Counts	Baseline to 16 weeks	Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).
Tolerability Assessments as Measured by the Number of Participants With Side Effects	16 weeks	Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus