Back to results

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

Primary Purpose

Acne Vulgaris, Post Inflammatory Hyperpigmentation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Azelaic acid

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

DermResearch, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Azelaic acid 15% (Finacea)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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%

Percentage Change in Total Lesion Counts

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

Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus

Full Information

NCT ID

NCT01038869

First Posted

December 23, 2009

Last Updated

August 24, 2012

Sponsor

Derm Research, PLLC

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01038869

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Derm Research, PLLC

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris, Post Inflammatory Hyperpigmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Azelaic acid 15% (Finacea)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Azelaic acid

Other Intervention Name(s)

Finacea

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)

Description

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.

Time Frame

Baseline to 16 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)

Description

IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement

Time Frame

Baseline to16 weeks

Title

Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution

Description

The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%

Time Frame

Baseline to 16 weeks

Title

Percentage Change in Total Lesion Counts

Description

Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).

Time Frame

Baseline to 16 weeks

Title

Tolerability Assessments as Measured by the Number of Participants With Side Effects

Description

Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leon H. Kircik, M.D.

Organizational Affiliation

DermResearch, PLLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

DermResearch, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs