Trial Outcomes & Findings for Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis (NCT NCT03491267)

NCT ID: NCT03491267

Last Updated: 2026-06-12

Results Overview

Change in number of new hairs, as assessed by manual counts using ImageJ dermatoscopic images

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

24 participants

Primary outcome timeframe

baseline and 9 weeks post treatment (up to 6 months of treatment)

Results posted on

2026-06-12

Participant Flow

24 participants were enrolled. 5 participants were lost to attrition before receiving treatment.

Participant milestones

Participant milestones
Measure
Subjects With Central Centrifugal Cicatricial Alopecia (CCCA)
All patients with Central Centrifugal Cicatricial Alopecia (CCCA) before and after laser and retinoic acid treatment. Patients are assigned treatment on one area, on the left or right side of the scalp on the basis of the individual's alopecia.
Overall Study
STARTED
19
Overall Study
COMPLETED
13
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Subjects With Central Centrifugal Cicatricial Alopecia (CCCA)
All patients with Central Centrifugal Cicatricial Alopecia (CCCA) before and after laser and retinoic acid treatment. Patients are assigned treatment on one area, on the left or right side of the scalp on the basis of the individual's alopecia.
Overall Study
Lost to Follow-up
6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CCCA Patients
n=24 Participants
All patients with Central centrifugal cicatricial alopecia (CCCA) before and after laser and retinoic acid treatment. Patients are assigned treatment on one area, on the left or right side of the scalp on the basis of the individual's alopecia.
Age, Categorical
<=18 years
0 Participants
n=9 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=9 Participants
Age, Categorical
>=65 years
4 Participants
n=9 Participants
Sex: Female, Male
Female
24 Participants
n=9 Participants
Sex: Female, Male
Male
0 Participants
n=9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
Race (NIH/OMB)
Asian
0 Participants
n=9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
Race (NIH/OMB)
Black or African American
24 Participants
n=9 Participants
Race (NIH/OMB)
White
0 Participants
n=9 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants

PRIMARY outcome

Timeframe: baseline and 9 weeks post treatment (up to 6 months of treatment)

Population: 6 participants were lost to follow-up after receiving treatment. Outcomes were compared pre- and post-treatment per protocol.

Change in number of new hairs, as assessed by manual counts using ImageJ dermatoscopic images

Outcome measures

Outcome measures
Measure
Post Treatment
n=13 Participants
after laser
Change in Number of New Hairs
2.6 hairs
Standard Deviation 5.89

Adverse Events

Subjects With Central Centrifugal Cicatricial Alopecia (CCCA)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Subjects With Central Centrifugal Cicatricial Alopecia (CCCA)
n=19 participants at risk
All patients with CCCA before and after laser and retinoic acid treatment. Patients are assigned treatment on one area, on the left or right side of the scalp on the basis of the individual's alopecia.
Skin and subcutaneous tissue disorders
mild pruritis and erythema
5.3%
1/19 • from start of treatment up to 9 weeks post-treatment (treatment duration up to 6 months)

Additional Information

Calvin O'Donnell

Johns Hopkins School of Medicine

Phone: 410-955-5933

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place