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Gentle Wounding for Hair Growth

Phase < 1
Waitlist Available
Led By Luis Garza, MD/PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject's CCCA is of grades 2, 3 or 4, as assessed at the time of the screening visit
The subject has clinical diagnosis of CCCA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year of treatment
Awards & highlights

Study Summary

This trial will test whether gentle wounding of the scalp can cause the generation of new hair follicles in humans.

Who is the study for?
This trial is for adults over 18 with a clinical diagnosis of Central Centrifugal Cicatricial Alopecia (CCCA) grades 2-4. Participants must be healthy, able to follow the study's protocol and visit schedule, and not have any skin conditions or tattoos in the treatment area. Pregnant or breastfeeding individuals, those with allergies to local anesthetics or antiseptics used in procedures, and anyone at risk due to medical conditions are excluded.Check my eligibility
What is being tested?
The study tests if gentle wounding on the scalp can stimulate new hair growth in humans as it does in mice. It involves mapping bald areas of the scalp then applying treatments like CO2 laser and retinoic acid. The treated areas will be monitored visually and through biopsies to check for hair regrowth.See study design
What are the potential side effects?
Potential side effects may include skin irritation from retinoic acid application, discomfort or pain from laser treatment, risks associated with biopsies such as infection or scarring, and possible allergic reactions to topical medications used during procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My CCCA is graded between 2 and 4.
Select...
I have been diagnosed with CCCA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hair follicle structure

Side effects data

From 2017 Phase 3 trial • 384 Patients • NCT02259088
8%
Upper respiratory tract infection
7%
Nasopharyngitis
6%
Cough
6%
Hypertension
5%
Urinary tract infection
5%
Intraocular pressure increased (Study eye)
4%
Dry eye (Study eye)
4%
Conjunctival haemorrhage (Study eye)
4%
Vitreous haemorrhage (Fellow eye)
3%
Dry eye (Fellow eye)
3%
Anaemia
3%
Hyperlipidaemia
3%
Diabetic nephropathy
2%
Coronary artery disease
2%
Vitreous haemorrhage (Study eye)
1%
Angina unstable
1%
Cerebral infarction
1%
Diabetic neuropathy
1%
Lung infection
1%
Pneumonia
1%
Diabetes mellitus inadequate control
1%
Hypoglycaemia
1%
Cataract (Fellow eye)
1%
Chronic obstructive pulmonary disease
1%
Diabetic vascular disorder
1%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ranibizumab (RFB002)
Laser

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects with alopecia-- area un-treatedExperimental Treatment1 Intervention
One area will be un-treated
Group II: Subjects with alopecia-- area treatedExperimental Treatment2 Interventions
One area will be treated
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retinoic acid
2015
Completed Early Phase 1
~50
Laser
2008
Completed Phase 4
~2170
Sham treatment
2013
Completed Phase 3
~1260

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,497 Total Patients Enrolled
Luis Garza, MD/PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Laser Clinical Trial Eligibility Overview. Trial Name: NCT03491267 — Phase < 1
Central Centrifugal Alopecia Research Study Groups: Subjects with alopecia-- area treated, Subjects with alopecia-- area un-treated
Central Centrifugal Alopecia Clinical Trial 2023: Laser Highlights & Side Effects. Trial Name: NCT03491267 — Phase < 1
Laser 2023 Treatment Timeline for Medical Study. Trial Name: NCT03491267 — Phase < 1
~4 spots leftby Dec 2025
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