Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis
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|ClinicalTrials.gov Identifier: NCT03491267|
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2018
Last Update Posted : January 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Central Centrifugal Cicatricial Alopecia (CCCA)||Drug: Retinoic acid Device: Laser Drug: Sham treatment Device: Sham treatment||Early Phase 1|
Central centrifugal cicatricial alopecia (CCCA) is a scarring, inflammatory alopecia seen more commonly in women of African descent. The distinct pathophysiology of CCCA is poorly understood, but it is known to involve inflammation directed at the upper part of the hair follicle where the stem cells and sebaceous gland are located. If the stem cells and sebaceous gland are destroyed, there is no possibility for regeneration of the hair follicle, and permanent hair loss results. This form of scarring alopecia occurs mainly on the vertex of the scalp, and spreads peripherally, and can lead to baldness. In our dermatology clinics, our investigators see 5-10 patients per week for evaluation and treatment of CCCA.
Currently, treatment is focused on decreasing inflammation and halting the progression of disease. This typically consists of topical and intralesional corticosteroid therapy and anti-inflammatory antibiotics. Hair transplantation is the only treatment option for patients with end-stage CCCA, and has been performed in a small number of patients but the results have been disappointing with low graft survival rates and slow regrowth of the transplanted hair. In addition, hair transplantation of the curved hair follicles found in patients of African descent is difficult and requires specific expertise.
A study by Ito et al showed de novo hair follicle formation after wounding in genetically normal adult mice. The regenerated hair follicles were fully functional, in that they established a stem cell population, expressed known molecular markers of follicle differentiation, and produced a hair shaft that progressed normally through all stages of the hair follicle cycle. It is hypothesized that the regenerated hair follicles likely arise when epithelial cells in the wound assume a hair follicle stem cell phenotype, possibly under the influence of Wnt signaling.
The CO2 laser has been used extensively in dermatological surgery over the past 30 years and is now recognized as the gold standard for soft tissue vaporization. CO2 laser beam heats and vaporizes the skin tissue, instantly removing the superficial layers of the skin. Each fractional micro-spot creates a thermal zone. Intact cells around the treated area help during the healing process which in turn, induces cell regeneration. This likely occurs through dsRNA released during wounding. The investigators have recently found that retinoids, such as the tretinoin (retin-A) used in acne, can synergize with dsRNA and promote extra Wnt signaling.
The investigators therefore hypothesize that wounding of the area of scarring alopecia in CCCA, using a fractionated CO2 laser in combination with retinoid acid, will induce hair follicle regeneration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Areas on a single scalp will be treated or untreated and monitored|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||assesors will be blinded|
|Primary Purpose:||Basic Science|
|Official Title:||Pilot Exploratory Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Subjects with alopecia-- area treated
One area will be treated
Drug: Retinoic acid
The study team will treat skin with topical retinoic acid
The study team treat skin with a surface laser.
Experimental: Subjects with alopecia-- area un-treated
One area will be un-treated
Drug: Sham treatment
No drug will be given
Device: Sham treatment
No laser treatment will be given
- Hair follicle neogenesis as counted by in vivo scanning confocal microscopy [ Time Frame: within 1 year of treatment ]appearance of new follicles, as defined by number of new follicles
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491267
|United States, Maryland|
|Johns Hopkins School of Medicine, Dermatology Department|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Luis Garza, MD/PhD||Johns Hopkins University|