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

Study Overview
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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.

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

Conditions
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Acne Vulgaris, Post Inflammatory Hyperpigmentation

Intervention / Treatment
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* Drug: Azelaic acid


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azelaic acid 15% (Finacea)<br>Open label pilot study, Topical gel to be appiled twice daily for 16 weeks | Drug: Azelaic acid<br>* 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.<br>* Other names: Finacea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment) | 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. | Baseline to 16 weeks | 

Secondary Outcome Measures

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