search
Back to results

Azelaic Acid on Demodex Counts in Rosacea

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azelaic acid
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea focused on measuring Rosacea, Wake Forest, Demodex, Finacea Gel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Health Sciences Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Azelaic acid

no treatment

Arm 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

no treatment on the other side of the face

Outcomes

Primary Outcome Measures

Demodex Count
number of demodex at Baseline and Week 4. Only Week 4 reported

Secondary Outcome Measures

Full Information

First Posted
December 19, 2012
Last Updated
August 8, 2018
Sponsor
Wake Forest University
search

1. Study Identification

Unique Protocol Identification Number
NCT03035955
Brief Title
Azelaic Acid on Demodex Counts in Rosacea
Official Title
The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2, 2012 (Actual)
Study Completion Date
February 2, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
Rosacea, Wake Forest, Demodex, Finacea Gel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
The investigator is blinded to which side of face is using the azelaeic acid treatetment
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azelaic acid
Arm Type
Active Comparator
Arm 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
Arm Title
no treatment
Arm Type
No Intervention
Arm Description
no treatment on the other side of the face
Intervention Type
Drug
Intervention Name(s)
Azelaic acid
Other Intervention Name(s)
Finacea Gel
Intervention Description
15% gel twice daily for four weeks to one side of face
Primary Outcome Measure Information:
Title
Demodex Count
Description
number of demodex at Baseline and Week 4. Only Week 4 reported
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Fleischer, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Azelaic Acid on Demodex Counts in Rosacea

We'll reach out to this number within 24 hrs