Phase 3
N=20
Azelaic Acid on Demodex Counts in Rosacea
Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT03035955 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Demodex Count — 40; 18 number of demodex
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Azelaic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Demodex Count |
40; 18 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03035955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.