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Antibiotic

Various Therapies for Central Centrifugal Alopecia (CCCA Trial)

Phase 4
Recruiting
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
with a clinical diagnosis and biopsy-proven CCCA, with Central Scalp Alopecia Scale severity 1 through 4 will be included in this study
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
Must not have
Patients who have undergone more than two rounds of intralesional steroid injections to the scalp in the past one year will be excluded
Patients who have been on long-term oral antibiotics for hair loss within the past year will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 4, month 6; visit 7, month 12; and visit 9, month 18-20
Awards & highlights

Summary

This trial looks at before and after photos of patients with CCCA to compare the effectiveness of different treatments.

Who is the study for?
This trial is for African-American women aged 18-60 with a specific type of hair loss called CCCA, confirmed by clinical diagnosis and biopsy. They must have a certain level of disease severity but haven't had multiple steroid scalp injections or long-term oral antibiotics for hair loss in the past year. Those who've used topical treatments for CCCA recently are also excluded.
What is being tested?
The study compares the effectiveness of different treatments on CCCA: Triamcinolone Acetonide (a steroid), class I-II topical steroids, Minoxidil (hair growth medication), and Doxycycline (an antibiotic). Patients' scalp photos before and after treatment will be used to assess results.
What are the potential side effects?
Possible side effects include skin irritation, changes in skin color at the site of application, headache from Minoxidil use, increased facial hair growth, and stomach upset or increased risk of sunburn from Doxycycline.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have CCCA with a severity level between 1 and 4.
Select...
I am an African-American woman, aged 18-60, with a confirmed CCCA diagnosis and mild to moderate scalp hair loss.
Select...
I am an African-American woman aged between 18 and 60.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had more than two steroid injections in my scalp in the last year.
Select...
I have not taken long-term antibiotics for hair loss in the past year.
Select...
I only have CCCA as my form of hair loss.
Select...
I haven't used any topical treatments for hair loss in the last 4 months.
Select...
I do not have any inflammatory scalp diseases except for mild seborrheic dermatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 4, month 6; visit 7, month 12; and visit 9, month 18-20
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 4, month 6; visit 7, month 12; and visit 9, month 18-20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Central Scalp Alopecia Photographic Scale in African American Women
Dermatology Life Quality Index (DLQI)
Hair Loss Questionnaire
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Topical steroid plus intralesional steroid injection groupActive Control3 Interventions
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
Group II: Topical steroid plus oral antibiotic groupActive Control3 Interventions
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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,457 Total Patients Enrolled
The Skin of Color SocietyUNKNOWN
Amy J McMichael, MDPrincipal InvestigatorWake Forest Baptist Health Department of Dermatology
2 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Doxycyline (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04207931 — Phase 4
Central Centrifugal Alopecia Research Study Groups: Topical steroid plus intralesional steroid injection group, Topical steroid plus oral antibiotic group
Central Centrifugal Alopecia Clinical Trial 2023: Doxycyline Highlights & Side Effects. Trial Name: NCT04207931 — Phase 4
Doxycyline (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04207931 — Phase 4
Central Centrifugal Alopecia Patient Testimony for trial: Trial Name: NCT04207931 — Phase 4
~34 spots leftby Sep 2025