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
COMPLETED
EARLY_PHASE1
24 participants
baseline and 9 weeks post treatment (up to 6 months of treatment)
2026-06-12
Participant Flow
24 participants were enrolled. 5 participants were lost to attrition before receiving treatment.
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
| 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
| 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
| 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 adverse events
Adverse event data not reported
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place