Azelaic Acid on Demodex Counts in Rosacea
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| 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 |
Drug: Azelaic acid
15% gel twice daily for four weeks to one side of face
Other Names:
|
| No Intervention: no treatment no treatment on the other side of the face |
Outcome Measures
Primary Outcome Measures
- Demodex Count [Week 4]
number of demodex at Baseline and Week 4. Only Week 4 reported
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Health Sciences Department of Dermatology | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University
Investigators
- Principal Investigator: Alan Fleischer, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00014511
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Azelaic Acid Left/No Treatment Right | Azelaic Acid Right/No Treatment Left |
|---|---|---|
| Arm/Group Description | azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face Azelaic acid: 15% gel twice daily for four weeks to the left side of face | azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face Azelaic acid: 15% gel twice daily for four weeks to the right side of face |
| Period Title: Overall Study | ||
| STARTED | 10 | 10 |
| COMPLETED | 9 | 9 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Azelaic Acid Left/No Treatment Right | Azelaic Acid Right/No Treatment Left | Total |
|---|---|---|---|
| Arm/Group Description | azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face | azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face | Total of all reporting groups |
| Overall Participants | 10 | 10 | 20 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
10
100%
|
10
100%
|
20
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
8
80%
|
9
90%
|
17
85%
|
| Male |
2
20%
|
1
10%
|
3
15%
|
Outcome Measures
| Title | Demodex Count |
|---|---|
| Description | number of demodex at Baseline and Week 4. Only Week 4 reported |
| Time Frame | Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Azelaic Acid Left/no Treatment Right | Azelaic Acid Right /no Treatment Left |
|---|---|---|
| Arm/Group Description | azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face | azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face |
| Measure Participants | 10 | 10 |
| Number [number of demodex] |
40
|
18
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Azelaic Acid | no Treatment | ||
| Arm/Group Description | 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 Azelaic acid: 15% gel twice daily for four weeks to one side of face | no treatment on the other side of the face | ||
All Cause Mortality |
||||
| Azelaic Acid | no Treatment | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Serious Adverse Events |
||||
| Azelaic Acid | no Treatment | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Azelaic Acid | no Treatment | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Director of Clinical Trials |
|---|---|
| Organization | WakeForest |
| Phone | 336-716-3775 |
- IRB00014511