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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mild wounding techniques can stimulate new hair follicle growth in individuals with certain types of hair loss. Researchers are testing methods such as using a gentle laser (a light-based treatment) on scalp areas lacking hair follicles to see if it promotes new hair growth. The goal is to develop new treatments for conditions like scarring alopecia, where current therapies prove ineffective. Individuals diagnosed with Central Centrifugal Cicatricial Alopecia (CCCA) and without issues that might hinder wound healing are well-suited for this study. As an Early Phase 1 trial, this research seeks to understand how the treatment functions in people, offering participants the chance to be among the first to experience this innovative approach.

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 prior data suggests that these gentle wounding techniques are safe for hair growth?

Research has shown that laser treatments, like those tested in this trial, are generally safe. These lasers work well for all skin types and are often used by individuals with thinning hair. Only minor side effects, such as slight redness or irritation, have been reported.

Similarly, retinoic acid, which some participants will also use, is usually safe when applied to the skin. If side effects occur, they are typically mild and may include dryness or peeling. Serious side effects are rare.

In early trials like this one, the main goal is to ensure the treatment is safe for participants. Although this trial is in its early stages, safety data from other studies has been encouraging. Participants can be hopeful that the treatments will be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the laser treatment for alopecia because it offers a new approach by using gentle wounding to stimulate hair growth. Unlike standard treatments like topical minoxidil or oral finasteride, which primarily target hormonal pathways or blood flow, this method works by creating tiny, controlled injuries that may activate the body's natural healing processes to encourage hair regrowth. This innovative mechanism could provide a faster and potentially more effective solution for those not responding well to existing treatments.

What evidence suggests that gentle wounding might be an effective treatment for alopecia?

This trial will compare the effects of laser treatment and retinoic acid on hair growth. Research has shown that lasers can promote hair regrowth, with some studies reporting a significant increase in hair count and a few participants experiencing up to 100% regrowth. Retinoic acid, commonly found in creams, can stimulate hair growth by activating typically inactive hair follicle stem cells. Specifically, about 58% of individuals using tretinoin, a form of retinoic acid, reported improvements. Overall, past studies have indicated that both laser treatments and retinoic acid hold promise for promoting hair regrowth. ^{4 6 7 8 9}

Who Is on the Research Team?

Luis Garza, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11023987/

Lasers in the management of alopecia: a review ... No significant increase in hair regrowth was observed; however, both the patients and clinicians endorsed clinical improvements in the hair ...

2. jcadonline.com jcadonline.com/laser-therapy-hair-loss/

A Systematic Review and Meta-analysis of Randomized ... The LLLT efficacy revealed a significant increase of terminal hair counts for 20.9/cm2 (12.79%, p=0.0249) versus 25.7/cm2 (16.96%, p=0.0028) in the 9- and 12- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8906269/

Role of Low-Level Light Therapy (LLLT) in Androgenetic ... Studies with largest randomized controlled trials demonstrated statistically significant hair regrowth by terminal hair count in both males and females. One ...

4. derma.jmir.org derma.jmir.org/2024/1/e60858/

Effectiveness of 675-nm Wavelength Laser Therapy in the ... The data reported in our study showed that there has been a 17% increase in hair length measurable parameters such as hair count, hair density, ...

5. ajmc.com ajmc.com/view/lasers-offer-new-options-for-hair-loss-treatment-in-alopecia-management

Lasers Offer New Options for Hair Loss Treatment in ... One study included in the review had a small sample size where 7 out of 8 patients experienced 100% hair regrowth and there were no serious ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7548873/

Examining the Safety and Efficacy of Low-Level Laser ... These laser devices have good safety profiles, with only minor adverse effects reported.

7. sacramentohairdoctor.com sacramentohairdoctor.com/blog/is-laser-hair-therapy-safe-myths-vs-facts-about-lllt/

Is Laser Hair Therapy Safe? Myths vs Facts About LLLT It is safe for all skin types and is commonly used by men and women with thinning hair. Common Myths About Laser Hair Therapy. Despite being a ...

8. med.stanford.edu med.stanford.edu/news/insights/2025/02/red-light-therapy-skin-hair-medical-clinics.html

Red light therapy: What the science says - Stanford Medicine Instead, they found that those receiving red light treatment sprouted more hair. Additional studies — in mice and in humans — bolstered evidence ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24474647/

Efficacy and safety of a low-level laser device in the treatment ... No serious adverse events were reported. Our results suggest that low-level laser treatment may be an effective option to treat pattern hair loss in both men ...