Central Centrifugal Cicatricial Alopecia (CCCA)Phase 4CCCANCT04207931
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
A Phase 4 study testing Topical steroid class I-II, Triamcinolone Acetonide and Doxycyline in people with Central Centrifugal Cicatricial Alopecia (CCCA), run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia (CCCA)
- What is being tested?
- Topical steroid class I-II, Triamcinolone Acetonide and Doxycyline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2018to Mar 2027
- Phase
- Phase 4
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- African-American women, ages 18-60 years old
- with a clinical diagnosis and biopsy-proven CCCA, with Central Scalp Alopecia Scale severity 1 through 4 will be included in this study
- These subjects will be seen and treated in Wake Forest Baptist Health Dermatology Outpatient Clinic
Who cannot join
- Patients with other forms of hair loss in addition to CCCA will be excluded
- Other patients to be excluded are those with other forms of inflammatory scalp disease (with the exception of mild seborrheic dermatitis)
- patients who have had topical treatment for CCCA within the past 4 months (including topical steroids, topical minoxidil, or any other topical hair regrowth medication)
- patients who have been on a long-term oral antibiotics for hair loss within the past year
- patients who have undergone more than two rounds of intralesional steroid injections to the scalp in the past one year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Baptist Health Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups
Read the detailed description
Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months. Both these regimens are used as the first-line treatments by clinicians. The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups.
In this study, the investigators are looking to determine how standard treatment affects the outcome of central centrifugal cicatricial alopecia; to determine if topical steroid with With Doxycycline has better outcome than topical steroids with intralesional steroids in central centrifugal cicatricial alopecia, and to determine how the addition of topical minoxidil as a treatment changes the outcome of central centrifugal cicatricial alopecia.
- Being tested
- Topical steroid class I-II, Triamcinolone Acetonide, Doxycyline, Minoxidil
- Keywords
- alopecia, Hair loss, Female hair loss, Minoxidil, Topical Steroid
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical steroid class I-IIDrug
Also called Clobetasol, Betamethasone Dipropionate, or Fluocinonide
applied once daily - 18 month duration of the study
Triamcinolone AcetonideDrug
Also called Kenaolog
Intralesional Steroid Injection, 7.5mg/cc. max dose of 3 cc. Scalp injections will be administered every 6-8 weeks, for a total of 8 injections.
DoxycylineDrug
Also called Doxy-100, Targadox, Oracea
oral antibiotic twice daily for 6 months
MinoxidilDrug
Also called Rogaine
5% solution or foam started after month 8
| Study group | Role | What they receive |
|---|---|---|
| Topical steroid plus oral antibiotic group | Active comparator | Participants in this group receive topical steroid (class I-II applied once daily) plus oral antibiotic group (doxycyline 100 mg twice daily for 6 months), and then topical minoxidil (5% solution or foam) after 8 months of treatment. Receives: Drug: Topical steroid class I-II; Drug: Doxycyline; Drug: Minoxidil |
| Topical steroid plus intralesional steroid injection group | Active comparator | Participants in this group receive topical steroid (class I-II applied once daily) plus intralesional steroid group (7.5mg/cc of kenaolog, max dose of 3 cc), and then topical minoxidil (5% solution or foam) after 8 months of treatment Receives: Drug: Topical steroid class I-II; Drug: Triamcinolone Acetonide; Drug: Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Scalp Alopecia Photographic Scale in African American Women
Photographs of the subject's scalp will be taken at baseline. This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
Measured: baseline
Central Scalp Alopecia Photographic Scale in African American Women
This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
Measured: Visit 4, Month 6
Secondary outcomes (4)
Hair Loss Questionnaire
Questionnaire gathers the epidemiologic data about the patient's hair loss, family history of hair loss, what treatments have been tried in the past, and hair care practices.
There is no range and/or direction as this questionnaire is used to gather descriptive data.
Measured: Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
Dermatology Life Quality Index (DLQI)
Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past week. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.
Measured: Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
Last Year Dermatology Life Quality Index (LYDLQI)
Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past year. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.
Measured: Baseline
Central Scalp Alopecia Photographic Scale in African American Women
This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
Measured: Visit 7, Month 12; Visit 9, Month 18-20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start30 Apr 2018
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Centrifugal Cicatricial Alopecia (CCCA)Studies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Skin of Color Society
- Responsible party
- Sponsor
- Investigators
- Amy J McMichael, MD, Principal investigator, Wake Forest Baptist Health Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207931
- Sponsor's protocol ID
- IRB00043796
- Acronym
- CCCA
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sperling LC, Sau P. The follicular degeneration syndrome in black patients. 'Hot comb alopecia' revisited and revised. Arch Dermatol. 1992 Jan;128(1):68-74.
PubMed 1739290Bin Saif GA, Ericson ME, Yosipovitch G. The itchy scalp--scratching for an explanation. Exp Dermatol. 2011 Dec;20(12):959-68. doi: 10.1111/j.1600-0625.2011.01389.x.
PubMed 22092575
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT04207931
- Acronym / sponsor ID
- CCCA / IRB00043796
- Keywords
- alopecia, Hair loss, Female hair loss, Minoxidil, Topical Steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Skin of Color Society
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Dec 2019 (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 objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups
Detailed description
Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months. Both these regimens are used as the first-line treatments by clinicians. The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups.
In this study, the investigators are looking to determine how standard treatment affects the outcome of central centrifugal cicatricial alopecia; to determine if topical steroid with With Doxycycline has better outcome than topical steroids with intralesional steroids in central centrifugal cicatricial alopecia, and to determine how the addition of topical minoxidil as a treatment changes the outcome of central centrifugal cicatricial alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months.
| Arm | Type | Receives |
|---|---|---|
| Topical steroid plus oral antibiotic group | Active comparator | Drug: Topical steroid class I-II, Drug: Doxycyline, Drug: MinoxidilParticipants in this group receive topical steroid (class I-II applied once daily) plus oral antibiotic group (doxycyline 100 mg twice daily for 6 months), and then topical minoxidil (5% solution or foam) after 8 months of treatment. |
| Topical steroid plus intralesional steroid injection group | Active comparator | Drug: Topical steroid class I-II, Drug: Triamcinolone Acetonide, Drug: MinoxidilParticipants in this group receive topical steroid (class I-II applied once daily) plus intralesional steroid group (7.5mg/cc of kenaolog, max dose of 3 cc), and then topical minoxidil (5% solution or foam) after 8 months of treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- African-American women, ages 18-60 years old
- with a clinical diagnosis and biopsy-proven CCCA, with Central Scalp Alopecia Scale severity 1 through 4 will be included in this study
- These subjects will be seen and treated in Wake Forest Baptist Health Dermatology Outpatient Clinic
Key exclusion criteria (5 listed)
- Patients with other forms of hair loss in addition to CCCA will be excluded
- Other patients to be excluded are those with other forms of inflammatory scalp disease (with the exception of mild seborrheic dermatitis)
- patients who have had topical treatment for CCCA within the past 4 months (including topical steroids, topical minoxidil, or any other topical hair regrowth medication)
- patients who have been on a long-term oral antibiotics for hair loss within the past year
- patients who have undergone more than two rounds of intralesional steroid injections to the scalp in the past one year.
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 |
|---|---|---|
| Topical steroid class I-IIAlso: Clobetasol, Betamethasone Dipropionate, or Fluocinonideapplied once daily - 18 month duration of the study | Drug | Topical steroid plus intralesional steroid injection group, Topical steroid plus oral antibiotic group |
| Triamcinolone AcetonideAlso: KenaologIntralesional Steroid Injection, 7.5mg/cc. max dose of 3 cc. Scalp injections will be administered every 6-8 weeks, for a total of 8 injections. | Drug | Topical steroid plus intralesional steroid injection group |
| DoxycylineAlso: Doxy-100, Targadox, Oraceaoral antibiotic twice daily for 6 months | Drug | Topical steroid plus oral antibiotic group |
| MinoxidilAlso: Rogaine5% solution or foam started after month 8 | Drug | Topical steroid plus intralesional steroid injection group, Topical steroid plus oral antibiotic group |
Primary outcome
Central Scalp Alopecia Photographic Scale in African American Women
Time frame: baseline
Photographs of the subject's scalp will be taken at baseline. This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
Central Scalp Alopecia Photographic Scale in African American Women
Time frame: Visit 4, Month 6
This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
4 secondary outcomes
Hair Loss Questionnaire
Time frame: Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
Dermatology Life Quality Index (DLQI)
Time frame: Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
Last Year Dermatology Life Quality Index (LYDLQI)
Time frame: Baseline
Central Scalp Alopecia Photographic Scale in African American Women
Time frame: Visit 7, Month 12; Visit 9, Month 18-20
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 31 Mar 2026.
- Background: PubMed 1739290Sperling LC, Sau P. The follicular degeneration syndrome in black patients. 'Hot comb alopecia' revisited and revised. Arch Dermatol. 1992 Jan;128(1):68-74.
- Background: PubMed 22092575Bin Saif GA, Ericson ME, Yosipovitch G. The itchy scalp--scratching for an explanation. Exp Dermatol. 2011 Dec;20(12):959-68. doi: 10.1111/j.1600-0625.2011.01389.x.
- 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.
Amy J McMichael, MD principal investigator
Wake Forest Baptist Health Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical steroid class I-II, Triamcinolone Acetonide and Doxycyline in people with Central Centrifugal Cicatricial Alopecia (CCCA), 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Mar 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. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Amy J McMichael, MD (336.716.3926, amcmichael@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Scalp Alopecia Photographic Scale in African American Women (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207931, which also lists 2 linked publications.
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 31 Mar 2026.