Central Centrifugal Cicatricial AlopeciaEarly Phase 1(CCCA)NCT05416333
Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
A Early Phase 1 study testing azelaic acid and usual medication for CCCA in people with Central Centrifugal Cicatricial Alopecia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if azelaic acid shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). In this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia
- What is being tested?
- azelaic acid and usual medication for CCCA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women eighteen years of age or older
- biopsy-proven and /or clinical diagnosis of CCCA Stage II-IV
- on stable treatment without changes for at least three months
- recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology
Who cannot join
- males
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Scieces
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
The purpose of this pilot study is to determine if azelaic acid shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). In this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle.
Read the detailed description
The management of Central Centrifugal Cicatricial Alopecia (CCCA) is challenging due to limited current treatments and a lack of randomized controlled trials. Management focuses on behavioral and styling modifications, in addition to symptomatic relief. Any potentially damaging hair care practices such as chemical relaxers, heat application to the scalp, and the use of hardening gels and sprays are discouraged. Many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos. These treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density. Currently, comparison studies of different treatments for CCCA subjects is limited. The aim is to determine if there is an advantage in using one particular anti-inflammatory therapy over another for relieving symptoms and promoting hair follicle regrowth.
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Being tested
- azelaic acid, usual medication for CCCA
- Keywords
- hair growth, hair follicle regrowth, hair loss regression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azelaic acidDrug
Also called Finacea
Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months
usual medication for CCCAOther
Subjects will continue to use their already prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months
| Study group | Role | What they receive |
|---|---|---|
| azelaic acid treatment | Experimental | Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months. Receives: Drug: azelaic acid |
| control (no additional treatment) | Sham comparator | 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. Receives: Other: usual medication for CCCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of hair loss regression
measured by standardized photos and dermatoscope photos
Measured: Baseline
Amount of hair loss regression
measured by standardized photos and dermatoscope photos
Measured: Month 2
Amount of hair loss regression
measured by standardized photos and dermatoscope photos
Measured: Month 4
Amount of hair loss regression
measured by standardized photos and dermatoscope photos
Measured: Month 6
Secondary outcomes (3)
Amount of hair regrowth
measured by standardized photos and dermatoscope photos
Measured: Months 2, 4, and 6
Amount of alleviation of signs and symptoms of disease
Higher scores means worse symptoms and signs of disease - Clinical signs and symptoms of CCCA will be documented by administering a standardized questionnaire to all subjects. Subjects will complete the standardized questionnaire regarding symptoms of their hair loss at the start of the enrollment and every 2 months until the study is completed.
Measured: Months 2, 4, and 6
Dermatology Life Quality Index (DLQI)
Scores of "not at all" to "very much"
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start12 Aug 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Centrifugal Cicatricial AlopeciaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 15 patients for the study will be randomized to one of two groups who consent to participate in a novel treatment with azelaic acid or the control (no additional treatment besides Subject's already prescribed drug)
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy J McMichael, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416333
- Sponsor's protocol ID
- IRB00076717
- Acronym
- (CCCA)
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
- ClinicalTrials.gov ID
- NCT05416333
- Acronym / sponsor ID
- (CCCA) / IRB00076717
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Keywords
- hair growth, hair follicle regrowth, hair loss regression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
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 pilot study is to determine if azelaic acid shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). In this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle.
Detailed description
The management of Central Centrifugal Cicatricial Alopecia (CCCA) is challenging due to limited current treatments and a lack of randomized controlled trials. Management focuses on behavioral and styling modifications, in addition to symptomatic relief. Any potentially damaging hair care practices such as chemical relaxers, heat application to the scalp, and the use of hardening gels and sprays are discouraged. Many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos. These treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density. Currently, comparison studies of different treatments for CCCA subjects is limited. The aim is to determine if there is an advantage in using one particular anti-inflammatory therapy over another for relieving symptoms and promoting hair follicle regrowth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 15 patients for the study will be randomized to one of two groups who consent to participate in a novel treatment with azelaic acid or the control (no additional treatment besides Subject's already prescribed drug)
| Arm | Type | Receives |
|---|---|---|
| azelaic acid treatment | Experimental | Drug: azelaic acidSubjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months. |
| control (no additional treatment) | Sham comparator | Other: usual medication for CCCASubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women eighteen years of age or older
- biopsy-proven and /or clinical diagnosis of CCCA Stage II-IV
- on stable treatment without changes for at least three months
- recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology
Key exclusion criteria (1 listed)
- males
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: FinaceaSubjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months | Drug | azelaic acid treatment |
| usual medication for CCCASubjects will continue to use their already prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months | Other | control (no additional treatment) |
Primary outcome
Amount of hair loss regression
Time frame: Baseline
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
Time frame: Month 2
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
Time frame: Month 4
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
Time frame: Month 6
measured by standardized photos and dermatoscope photos
3 secondary outcomes
Amount of hair regrowth
Time frame: Months 2, 4, and 6
Amount of alleviation of signs and symptoms of disease
Time frame: Months 2, 4, and 6
Dermatology Life Quality Index (DLQI)
Time frame: Baseline and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- 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.
Amy J McMichael, 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 Early Phase 1 study testing azelaic acid and usual medication for CCCA in people with Central Centrifugal Cicatricial Alopecia, run by Wake Forest University Health Sciences 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Amount of hair loss regression (time frame: Baseline). The study lists 4 primary outcomes in all. 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 1 Jul 2026.