Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis

NCT03491267 | Completed Early Phase 1 FDA Drug FDA Device

• 1 other identifier: IRB00105061
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Centrifugal Cicatricial Alopecia (CCCA)

Keywords

alopecia

Outcome Measures

Primary Outcomes (1)

• Hair follicle neogenesis as counted by in vivo scanning confocal microscopy

  appearance of new follicles, as defined by number of new follicles

  within 1 year of treatment

Study Arms (2)

Subjects with alopecia-- area treated

EXPERIMENTAL

One area will be treated

Drug: Retinoic acid; Device: Laser

Subjects with alopecia-- area un-treated

EXPERIMENTAL

One area will be un-treated

Drug: Sham treatment; Device: Sham treatment

Interventions

Retinoic acid DRUG

The study team will treat skin with topical retinoic acid

Subjects with alopecia-- area treated

Laser DEVICE

The study team treat skin with a surface laser.

Subjects with alopecia-- area treated

Sham treatment DRUG

No drug will be given

Subjects with alopecia-- area un-treated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female older than 18 at the screening visit;
• The subject is healthy, as determined by the investigator based on a medical evaluation including medical history;
• The subject has clinical diagnosis of CCCA;
• The subject's CCCA is of grades 2, 3 or 4, as assessed at the time of the screening visit.
• The subject is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visits schedule, concomitant therapy and hair processing prohibitions, subject instructions, and biopsy procedures;
• The subject is willing to comply with the month long washout period if deemed necessary;

You may not qualify if:

• The subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
• The subject presents with any disease known or described to potentially interfere with a normal wound healing process
• The subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period (by self report)
• 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)
• The subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
• The subject has scars, sunburn, either damaged or broken (cuts or abrasions) skin or other blemishes, or tattoos on the scalp in the treatment area
• The subject is unwilling or unable to refrain from specific types of chemical hair styling and processing, including perms, straighteners, relaxers, dyes, weaves
• The subject has a known allergy or sensitivity to any local anesthetic drug (e.g. lidocaine) or a local antiseptic planned to be used for the laser and/or biopsy procedures
• The subject is an adult under guardianship or is hospitalized in a public or private institution, or is deprived of freedom
• The subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute Of Arthritis & Musculoskeletal & Skin Diseases: collaborator

Study Sites (1)

Johns Hopkins School of Medicine, Dermatology Department

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Tretinoin; Lasers

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Luis Garza, MD/PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assesors will be blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Areas on a single scalp will be treated or untreated and monitored

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 9, 2018
• Study Start: January 1, 2018
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

US (1)