20 Participants Needed

Gentle Wounding for Hair Growth

Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Johns Hopkins University
Must be taking: Topical retinoids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions a possible month-long washout period (time without taking certain medications) if deemed necessary.

What data supports the effectiveness of the Gentle Wounding for Hair Growth treatment?

The research on laser hair removal shows that lasers can effectively target hair follicles, leading to reduced hair growth and finer hair regrowth. This suggests that laser treatment, as part of the Gentle Wounding for Hair Growth approach, may help stimulate hair growth by affecting hair follicles.12345

Is gentle wounding for hair growth safe?

Laser treatments, which are a form of gentle wounding, are generally safe but can have side effects like temporary pain, redness, swelling, and rare cases of purpura (bruising). Proper training and regulation are important to minimize risks.678910

How does the gentle wounding laser treatment for hair growth differ from other treatments?

The gentle wounding laser treatment for hair growth is unique because it uses a laser to create controlled, minor injuries to the skin, which can stimulate hair growth by enhancing the environment around hair follicles. This approach differs from other treatments that may focus on removing hair or using topical solutions, as it leverages the body's natural healing processes to promote hair regrowth.111121314

What is the purpose of this trial?

The investigators have extensive evidence in mouse that wounding leads to the generation of new hair follicles in the skin. This can be an important new therapy for patients with scarring, but especially those with alopecia.The question is whether gentle wounding in human subjects can cause the generation of a new hair follicle.The plan is to first carefully map a small area of the scalp without hair follicles. Investigators will then try various modalities of gentle wounding (including fractionated Carbon Dioxide (CO2) laser, mild curetting) of the surface epithelium in the presence and absence of FDA approved topical medications (including retinoids). Investigators will then prospectively monitor the area for hair growth both by noninvasive visual monitoring (including photographs and dermoscopy) and biopsies.The outcomes of this study hopefully will allow new therapies for especially scarring alopecia conditions where hair follicles are completely lost and there are no current therapies.

Research Team

LG

Luis Garza, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to follow all study requirements, including visit schedules and instructions.
The subject is willing to comply with the month long washout period if deemed necessary
My CCCA is graded between 2 and 4.
See 4 more

Exclusion Criteria

I have a health condition that could make participating risky.
I have had issues with blood clotting in the past.
I have had issues with abnormal scarring or keloids in the last 10 years.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Various modalities of gentle wounding, including fractionated CO2 laser and mild curetting, are applied to the scalp in the presence and absence of FDA approved topical medications

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for hair growth through noninvasive visual monitoring and biopsies

40 weeks
3 visits (in-person)

Treatment Details

Interventions

  • Laser
  • Retinoic acid
  • Sham treatment
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institute Of Arthritis & Musculoskeletal & Skin Diseases

Collaborator

Trials
1
Recruited
20+

Findings from Research

In a study involving subjects with Fitzpatrick skin types II-V, three different laser firing modes for hair removal showed high efficacy, with mean hair clearance percentages of 83% for the alexandrite laser, and 81% and 86% for the multiplexed pulse combinations.
All treatment methods had minimal side effects, indicating that the multiplexed laser pulses are as safe as the traditional alexandrite laser while providing comparable effectiveness in removing unwanted axillary hair.
Bilateral axilla hair removal comparing a single wavelength alexandrite laser with combined multiplexed alexandrite and Nd:YAG laser treatment from a single laser platform.Bernstein, EF., Basilavecchio, L., Plugis, J.[2012]

References

Ruby laser-assisted hair removal reduces the coarseness of regrowing hairs: fallacy or fact? [2007]
Bilateral axilla hair removal comparing a single wavelength alexandrite laser with combined multiplexed alexandrite and Nd:YAG laser treatment from a single laser platform. [2012]
Laser hair removal. [2004]
Laser hair removal: guidelines for management. [2018]
Laser-assisted hair removal. [2019]
Purpura induced by laser hair removal: a case report. [2018]
Axillary hair removal with 1064-nm Nd:YAG laser increases sweat production. [2015]
Simulated consumer use of a battery-powered, hand-held, portable diode laser (810 nm) for hair removal: A safety, efficacy and ease-of-use study. [2015]
Hair induction after laser-assisted hair removal and its treatment. [2022]
The "in's and outs" of laser hair removal: a mini review. [2020]
[Effect of alexandrite laser treatment for hair removal in Tibet mini-pigs]. [2009]
Histological studies of the effects of wounding vibrissa follicles in the hooded rat. [2006]
Therapeutic efficacy and safety of a 1927-nm fractionated thulium laser on pattern hair loss: an evaluator-blinded, split-scalp study. [2022]
Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors. [2022]
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