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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris; Post Inflammatory Hyperpigmentation
• Intervention / Treatment: Drug: Azelaic acid

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Derm Research, PLLC
• Collaborators: Bayer
• Investigators: Principal Investigator: Leon H. Kircik, M.D., DermResearch, PLLC

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Estimate): September 25, 2012
• Last Update Submitted That Met QC Criteria: August 24, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Pigmentation Disorders; Acne Vulgaris; Hyperpigmentation; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: FIN0901