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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
Must not have
The subject has a past history of coagulation trouble
The subject has a past history of abnormal healing (hypertrophic scars/keloids within the past 10 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year of treatment
Awards & highlights
No Placebo-Only Group

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.
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.
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
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My CCCA is graded between 2 and 4.
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I have been diagnosed with CCCA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had issues with blood clotting in the past.
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I have had issues with abnormal scarring or keloids in the last 10 years.
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I am willing to avoid certain hair treatments like dyes or perms.
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I have scars, sunburn, cuts, or tattoos on my scalp where treatment is planned.
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I am allergic to certain local anesthetics or antiseptics used in medical procedures.
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I am an adult under guardianship or currently institutionalized or deprived of freedom.
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I am unable to communicate or cooperate with my doctor due to language barriers or mental impairments.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hair follicle structure

Side effects data

From 2017 Phase 3 trial • 384 Patients • NCT02259088
12%
Hypertension
9%
Nasopharyngitis
5%
Alanine aminotransferase increased
4%
Hyperlipidaemia
4%
Urinary tract infection
4%
Vitreous haemorrhage (Study eye)
4%
Vitreous haemorrhage (Fellow eye)
3%
Cough
3%
Diabetic foot
3%
Upper respiratory tract infection
3%
Diabetes mellitus inadequate control
3%
Diabetic retinal oedema (Fellow eye)
1%
Dry eye (Fellow eye)
1%
Ascites
1%
Diabetic nephropathy
1%
Colon cancer
1%
Conjunctival haemorrhage (Study eye)
1%
Dry eye (Study eye)
1%
Diabetic neuropathy
1%
Facial paralysis
1%
Chronic kidney disease
1%
Retinal detachment (Fellow eye)
1%
Bronchitis
1%
Hepatitis B
1%
Hepatic cirrhosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laser
Ranibizumab (RFB002)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

National Institute Of Arthritis & Musculoskeletal & Skin DiseasesUNKNOWN
Johns Hopkins UniversityLead Sponsor
2,332 Previous Clinical Trials
14,874,880 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
~3 spots leftby Dec 2025
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