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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038869
• Other study ID #: FIN0901
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2009
• Last updated: August 24, 2012
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2012
• Source: Derm Research, PLLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris
• Hyperpigmentation
• Post Inflammatory Hyperpigmentation

Intervention

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.

Locations

Country	Name	City	State
United States	DermResearch, PLLC	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Derm Research, PLLC	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes