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Phase 3 N=20 Randomized Single-blind Treatment

Azelaic Acid on Demodex Counts in Rosacea

Rosacea

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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