Gentle Wounding for Hair Growth

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Johns Hopkins University

Must be taking: Topical retinoids

Disqualifiers: Pregnancy, Coagulation issues, Abnormal healing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 11 12 13 14}

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

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.

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.

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

Group I: Subjects with alopecia-- area un-treated Experimental Treatment 1 Intervention

One area will be un-treated

Group II: Subjects with alopecia-- area treated Experimental Treatment 2 Interventions

One area will be treated

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. England pubmed.ncbi.nlm.nih.gov

Ruby laser-assisted hair removal reduces the coarseness of regrowing hairs: fallacy or fact? [2007]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Laser hair removal. [2004]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Laser hair removal: guidelines for management. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Laser-assisted hair removal. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Purpura induced by laser hair removal: a case report. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Axillary hair removal with 1064-nm Nd:YAG laser increases sweat production. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

Hair induction after laser-assisted hair removal and its treatment. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The "in's and outs" of laser hair removal: a mini review. [2020]

11. China pubmed.ncbi.nlm.nih.gov

[Effect of alexandrite laser treatment for hair removal in Tibet mini-pigs]. [2009]

12. England pubmed.ncbi.nlm.nih.gov

Histological studies of the effects of wounding vibrissa follicles in the hooded rat. [2006]

13. England pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy and safety of a 1927-nm fractionated thulium laser on pattern hair loss: an evaluator-blinded, split-scalp study. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors. [2022]