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Azelaic Acid for Central Centrifugal Cicatricial Alopecia ((CCCA) Trial)
Phase < 1
Waitlist Available
Led By Amy J McMichael, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
biopsy-proven and /or clinical diagnosis of CCCA Stage II-IV
Biopsy-proven and/or clinical diagnosis of CCCA Stage II-IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 2, 4, and 6
Awards & highlights
(CCCA) Trial Summary
This trial is testing whether azelaic acid could be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA), by comparing it to a placebo. Azelaic acid may help by reducing inflammation that affects the hair growth cycle.
Who is the study for?
This trial is for women over 18 with a confirmed diagnosis of Central Centrifugal Cicatricial Alopecia (CCCA) stages II-IV. Participants must have been on a stable treatment plan for at least three months without changes, and they are recruited from outpatient dermatology clinics.Check my eligibility
What is being tested?
The study tests azelaic acid's effectiveness against CCCA compared to a placebo. Azelaic acid is thought to reduce inflammation that can interfere with hair growth. This pilot study aims to see if it could be an effective treatment option.See study design
What are the potential side effects?
While the specific side effects in this trial aren't listed, azelaic acid generally may cause skin irritation, burning sensation, itching or redness where applied.
(CCCA) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is diagnosed as Stage II-IV CCCA.
Select...
My condition is diagnosed as Stage II-IV CCCA.
(CCCA) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 2, 4, and 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 2, 4, and 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount of hair loss regression
Secondary outcome measures
Amount of alleviation of signs and symptoms of disease
Amount of hair regrowth
Dermatology Life Quality Index (DLQI)
(CCCA) Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: azelaic acid treatmentExperimental Treatment1 Intervention
Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.
Group II: control (no additional treatment)Placebo Group1 Intervention
Subjects will continue to use their current primary provider prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,222 Total Patients Enrolled
Amy J McMichael, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
290 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 18 or older.My current treatment has not changed for at least three months.I am male.My condition is diagnosed as Stage II-IV CCCA.I am a woman aged 18 or older.My current treatment has been the same for at least three months.My condition is diagnosed as Stage II-IV CCCA.
Research Study Groups:
This trial has the following groups:- Group 1: azelaic acid treatment
- Group 2: control (no additional treatment)
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Central Centrifugal Alopecia Patient Testimony for trial: Trial Name: NCT05416333 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide details on how to apply for the current research initiative?
"Clinicaltrials.gov indicates that this investigation is not presently taking on new patients, as the trial was first posted on January 1st 2023 and most recently updated on November 28th 2022. However, there are 86 other clinical trials in progress at this time seeking participants."
Answered by AI
Who else is applying?
What state do they live in?
Texas
North Carolina
How old are they?
18 - 65
What site did they apply to?
Wake Forest University Health Scieces
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I’m hoping this clinical trial will help my condition. As a woman your hair is your crown and losing it is very difficult and depressing .
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do screening visits take? How many visits will you have to attend? How long before you see results?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- Wake Forest University Health Scieces: < 48 hours
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