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RecruitingNCT04207931CCCAUpdated Mar 31, 2026

Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study

A Phase 4 interventional study of Topical steroid class I-II and Triamcinolone Acetonide in Central Centrifugal Cicatricial Alopecia (CCCA), sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Apr 2018, registered Dec 2019).
  • Started Apr 2018; still recruiting 8 years 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Central Centrifugal Cicatricial Alopecia (CCCA)

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Keywords

  • alopecia
  • Hair loss
  • Female hair loss
  • Minoxidil
  • Topical Steroid
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 250 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • African-American women, ages 18-60 years old
  • with a clinical diagnosis and -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

Exclusion criteria

Exclusion Criteria:

  • 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 , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • Active comparator
    Topical steroid plus oral antibiotic group

    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.

    Drug: Topical steroid class I-II · Drug: Doxycyline · Drug: Minoxidil

  • Active comparator
    Topical steroid plus intralesional steroid injection group

    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

    Drug: Topical steroid class I-II · Drug: Triamcinolone Acetonide · Drug: Minoxidil

Interventions

  • DrugTopical steroid class I-II

    applied once daily - 18 month duration of the study

    Also known as: Clobetasol, Betamethasone Dipropionate, or Fluocinonide

  • 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.

    Also known as: Kenaolog

  • oral antibiotic twice daily for 6 months

    Also known as: Doxy-100, Targadox, Oracea

  • 5% solution or foam started after month 8

    Also known as: Rogaine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: Visit 4, Month 6

Secondary outcomes

  1. 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.

    Time frame: Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20

  2. 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.

    Time frame: Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Visit 7, Month 12; Visit 9, Month 18-20

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 1739290 ↗
  • Bin 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2018 (actual). Primary completion is estimated for Nov 2026, 103 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2019
First posted
Dec 23, 2019
StartActual
Apr 30, 2018
Primary completionEst.
Nov 2026
CompletionEst.
Mar 2027
Last update
Mar 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04207931
Collaborators
The Skin of Color Society
Responsible party
Sponsor
First posted
Dec 23, 2019
Start date
Apr 30, 2018
Primary completion
Nov 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Mar 31, 2026

Study contacts

Amy J McMichael, MD
Contact
amcmichael@wakehealth.edu
336.716.3926
Judy Holbrook, CRC
Contact
jholbroo@wakehealth.edu
336.716.8991
Amy J McMichael, MD
principal investigator · Wake Forest Baptist Health Department of Dermatology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Triamcinolone Acetonide · Doxycycline

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