Azelaic Acid on Demodex Counts in Rosacea

NCT03035955 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00014511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Keywords

Rosacea; Wake Forest; Demodex; Finacea Gel

Outcome Measures

Primary Outcomes (1)

• Demodex Count

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

  Week 4

Study Arms (2)

Azelaic acid

ACTIVE COMPARATOR

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

no treatment

NO INTERVENTION

no treatment on the other side of the face

Interventions

Azelaic acid DRUG

15% gel twice daily for four weeks to one side of face

Also known as: Finacea Gel

Azelaic acid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: WakeForest

336-716-3775

Study Officials

• Alan Fleischer, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator is blinded to which side of face is using the azelaeic acid treatetment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: January 30, 2017
• Study Start: December 1, 2010
• Primary Completion: February 2, 2012
• Study Completion: February 2, 2012
• Last Updated: September 7, 2018
• Results First Posted: May 30, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)