NCT01038869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 25, 2012

Completed
Last Updated

September 25, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

December 23, 2009

Results QC Date

March 26, 2012

Last Update Submit

August 24, 2012

Conditions

Acne VulgarisPost Inflammatory Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    Baseline to16 weeks

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

    Baseline to 16 weeks

  • Percentage Change in Total Lesion Counts

    Baseline to 16 weeks

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

    16 weeks

Study Arms (1)

Azelaic acid 15% (Finacea)

EXPERIMENTAL

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

Drug: Azelaic acid

Interventions

Azelaic acidDRUG

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.

Also known as: Finacea
Azelaic acid 15% (Finacea)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Acne VulgarisHyperpigmentation

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesPigmentation Disorders

Limitations and Caveats

This is an open-label study with a small number of subjects.

Results Point of Contact

Title
Leon Kircik, M.D.
Organization
DermResearch, PLLC
wedoderm@yahoo.com
502-451-9000

Study Officials

  • Leon H. Kircik, M.D.

    DermResearch, PLLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 24, 2009

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

September 25, 2012

Results First Posted

September 25, 2012

Record last verified: 2012-08

Locations

US(1)