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Antibiotic

Various Therapies for Central Centrifugal Alopecia (CCCA Trial)

Q: To what end are Topical steroid plus intralesional steroid injection regimens typically employed?

<p>Severe <a href="https://www.withpower.com/clinical-trials/acne">acne</a>, <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>, and other dermatological issues can be managed with a combination of topical steroid treatment and intralesional corticosteroid injections.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

CCCA Trial 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.Check my eligibility

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.See study design

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.

CCCA Trial 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.

CCCA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Central Scalp Alopecia Photographic Scale in African American Women

Dermatology Life Quality Index (DLQI)

Hair Loss Questionnaire

+1 more

CCCA 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,241 Previous Clinical Trials

1,003,987 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what kind of individuals is this experiment an appropriate fit?

"This research project is taking in up to 250 individuals between 18 and 60 years of age who have been clinically diagnosed with central centrifugal cicatricial alopecia (CCCA). This study requires that patients be African-American women, arriving at Wake Forest Baptist Health Dermatology Outpatient Clinic, with a Central Scalp Alopecia Scale severity ranging from 1 to 4."

Answered by AI

Are recruitment efforts underway for this study?

"According to the clinicaltrials.gov website, this trial is presently recruiting patients and has been since April 30th 2018 when it was first posted. It was recently updated on September 26th 2022."

Answered by AI

Has there been prior research done on the combination of topically-applied steroids and injectable corticosteroids?

"Currently, 95 clinical trials are examining the efficiency of Topical steroid plus intralesional steroid injection group. Of those experiments, 21 are in their third phase as of now. Most studies for this treatment occur in Harrison, New york; however there exist a total of 299 sites running research on the matter."

Answered by AI

What is the magnitude of people involved in this clinical experiment?

"Affirmative, the trial is actively recruiting. According to data hosted on clinicaltrials.gov, this study was first posted April 30th 2018 and most recently updated September 26th 2022; it seeks 250 patients from a single site."

Answered by AI

Does this research involve any individuals who have surpassed 45 years of age?

"In agreement with the eligibility criteria, prospective participants must be no older than 60 years old and at least 18."

Answered by AI

To what end are Topical steroid plus intralesional steroid injection regimens typically employed?

"Severe acne, ulcerative colitis, and other dermatological issues can be managed with a combination of topical steroid treatment and intralesional corticosteroid injections."

Answered by AI

What possible adverse effects could be incurred by individuals taking part in the topical steroid plus intralesional steroid injection group?

"There is ample evidence that Topical steroid plus intralesional steroid injection group carries a safe rating of 3, as this treatment has been approved for Phase 4 trials."

Answered by AI