Rosacea
Conditions
Keywords
Rosacea, Wake Forest, Demodex, Finacea Gel
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.
Interventions
DRUGAzelaic acid
15% gel twice daily for four weeks to one side of face
Sponsors
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The investigator is blinded to which side of face is using the azelaeic acid treatetment
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demodex Count | Week 4 | number of demodex at Baseline and Week 4. Only Week 4 reported |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azelaic Acid Left/No Treatment Right azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face | 10 |
| Azelaic Acid Right/No Treatment Left azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Azelaic Acid Left/No Treatment Right | Azelaic Acid Right/No Treatment Left | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Demodex Count
number of demodex at Baseline and Week 4. Only Week 4 reported
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azelaic Acid Left/no Treatment Right | Demodex Count | 40 number of demodex |
| Azelaic Acid Right /no Treatment Left | Demodex Count | 18 number of demodex |