RosaceaPhase 2/3NCT03035955
Azelaic Acid on Demodex Counts in Rosacea
A Phase 2/3 study testing Azelaic acid in people with Rosacea, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rosacea
- What is being tested?
- Azelaic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 2 Feb 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea
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.
Read the 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.
- Conditions
- Rosacea
- Being tested
- Azelaic acid
- Keywords
- Rosacea, Wake Forest, Demodex, Finacea Gel
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic acidDrug
Also called Finacea Gel
15% gel twice daily for four weeks to one side of face
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Azelaic acid |
| no treatment | No intervention | no treatment on the other side of the face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demodex Count
number of demodex at Baseline and Week 4. Only Week 4 reported
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startDec 2010
- Primary completion2 Feb 2012
- Study completion2 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Fleischer, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035955
- Sponsor's protocol ID
- IRB00014511
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2012
- Last updated
- 7 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT03035955
- Acronym / sponsor ID
- IRB00014511
- Conditions
- Rosacea
- Keywords
- Rosacea, Wake Forest, Demodex, Finacea Gel
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- 2 Feb 2012 (actual)
- Study completion
- 2 Feb 2012 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Azelaic acid | Active comparator | Drug: Azelaic acidazelaic 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 | No intervention | –no treatment on the other side of the face |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azelaic acidAlso: Finacea Gel15% gel twice daily for four weeks to one side of face | Drug | Azelaic acid |
Primary outcome
Demodex Count
Time frame: Week 4
number of demodex at Baseline and Week 4. Only Week 4 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Fleischer, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Azelaic acid in people with Rosacea, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demodex Count (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.