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Azelaic Acid on Demodex Counts in Rosacea

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ClinicalTrials.gov Identifier: NCT03035955
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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
Rosacea Drug: Azelaic acid 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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 (based on Investigator Global Assessment) 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 (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.
Masking: Single (Investigator)
Masking Description: The investigator is blinded to which side of face is using the azelaeic acid treatetment
Primary Purpose: Treatment
Official Title: The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea
Study Start Date : December 2010
Actual Primary Completion Date : February 2, 2012
Actual Study Completion Date : February 2, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

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 Name: Finacea Gel
No Intervention: no treatment
no treatment on the other side of the face



Primary Outcome Measures :
  1. Demodex Count [ Time Frame: Week 4 ]
    number of demodex at Baseline and Week 4. Only Week 4 reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035955


Locations
United States, North Carolina
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

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT03035955     History of Changes
Other Study ID Numbers: Intendis - Demodex Rosacea
First Posted: January 30, 2017    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Rosacea
Wake Forest
Demodex
Finacea Gel

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents