- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035955
Azelaic Acid on Demodex Counts in Rosacea
August 8, 2018 updated by: Wake Forest University
The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea
The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum counts and disease condition via a split face design in approximately twenty patients with mild to moderate rosacea.
The investigators hypothesize that treatment of rosacea with azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement in lesion count and redness.
Study Overview
Detailed Description
This is a split face, randomized, single blind, single center study.
Male and female (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular facial rosacea, with bilateral facial involvement, and no more than two nodules will be enrolled.
Subjects will be randomized 1:1 by the study coordinator using a standard randomization table to receive azelaic acid twice daily on either the left side or the right side of the face and no treatment on the other side of the face.
Subjects must have a positive Demodex folliculorum standardized skin surface biopsy, defined at >5 mites cm at Screening/Baseline on at least one of two different SSSB specimens on bilateral sides of the face.
The SSSB test location will ideally be on the cheek, but may be done in the most disease involved area.
Subjects will be seen at Screening/Baseline, Week 1 and Week 4. Standard topical washout periods will be observed.
At each visit, rosacea will be evaluated by lesion count, IGA and two Demodex SSSB tests done on each side of the face.
Safety will be monitored at each visit using the Investigator Skin Irritation Assessment.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences Department of Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects, ages 18 and over, with mild to moderate paulopustular rosacea with bilateral facila involvement, who agrees to participate and provide written consent.
- Positive Demodex folliculorum SSSB, defined as >5 mites/cm on at least on of two different SSSB specimens on bilateral sides of teh face.
- Have an IGA of mild to moderate rosacea, rating between 2 and 5.
Exclusion Criteria:
- Use of topical therapy for rosacea or other skin conditions on the face within two weeks of Baseline.
- Use of oral medications for the treatment of rosacea that have been started or altered within the past three months.
- Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
- Subjects with known allergy or sensitivity to azelaic acid gel or components therein, such as propylene glycol.
- Subjects with known allergy or sensitivity to cyanoacrylates or formaldehyde.
- Presence of more than two nodules.
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device, DepoProvera, tubal ligation or vasectomy of the partner in a monogamous relationship. An acceptable, though less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Azelaic acid
azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face
|
15% gel twice daily for four weeks to one side of face
Other Names:
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No Intervention: no treatment
no treatment on the other side of the face
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demodex Count
Time Frame: Week 4
|
number of demodex at Baseline and Week 4.
Only Week 4 reported
|
Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan Fleischer, MD, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
February 2, 2012
Study Completion (Actual)
February 2, 2012
Study Registration Dates
First Submitted
December 19, 2012
First Submitted That Met QC Criteria
January 26, 2017
First Posted (Estimate)
January 30, 2017
Study Record Updates
Last Update Posted (Actual)
September 7, 2018
Last Update Submitted That Met QC Criteria
August 8, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00014511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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