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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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

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I have CCCA with a severity level between 1 and 4.

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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:

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I have not had more than two steroid injections in my scalp in the last year.

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I have not taken long-term antibiotics for hair loss in the past year.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 4, month 6; visit 7, month 12; and visit 9, month 18-20

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met