Central Centrifugal Cicatricial Alopecia (CCCA)Early Phase 1NCT03491267
Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis
A Early Phase 1 study testing Retinoic acid and Laser in people with Central Centrifugal Cicatricial Alopecia (CCCA), run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia (CCCA)
- What is being tested?
- Retinoic acid and Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Nov 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet the following inclusion criteria will be included in the study:
- 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;
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- The subject is willing to comply with the month long washout period if deemed necessary;
- The subject has understood and signed an Informed Consent Form approved by the Institutional Review Board (IRB) prior to any investigational procedure Exclusion criteria
- Any subject who is meeting one or more of the following exclusion criteria at the screening visit and/or at the baseline visit will not be included in this study:
- 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 in an exclusion period from a previous study or is participating in another clinical trial
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine, Dermatology Department
Baltimore, Maryland, 21287
About this study
Official title: Pilot Exploratory Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Retinoic acid, Laser, Sham treatment
- Keywords
- alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinoic acidDrug
The study team will treat skin with topical retinoic acid
LaserDevice
The study team treat skin with a surface laser.
Sham treatmentDrug
No drug will be given
Sham treatmentDevice
No laser treatment will be given
| Study group | Role | What they receive |
|---|---|---|
| Subjects with alopecia-- area treated | Experimental | One area will be treated Receives: Drug: Retinoic acid; Device: Laser |
| Subjects with alopecia-- area un-treated | Experimental | One area will be un-treated Receives: Drug: Sham treatment; Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of New Hairs
Change in number of new hairs, as assessed by manual counts using ImageJ dermatoscopic images
Measured: baseline and 9 weeks post treatment (up to 6 months of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Jan 2018
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Centrifugal Cicatricial Alopecia (CCCA)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Areas on a single scalp will be treated or untreated and monitored
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute Of Arthritis & Musculoskeletal & Skin Diseases
- Responsible party
- Sponsor
- Investigators
- Luis Garza, MD/PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491267
- Sponsor's protocol ID
- IRB00105061
- Status last verified
- May 2026
- First submitted
- 23 Mar 2018
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Exploratory Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis
- ClinicalTrials.gov ID
- NCT03491267
- Acronym / sponsor ID
- IRB00105061
- Keywords
- alopecia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute Of Arthritis & Musculoskeletal & Skin Diseases
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Areas on a single scalp will be treated or untreated and monitored
| Arm | Type | Receives |
|---|---|---|
| Subjects with alopecia-- area treated | Experimental | Drug: Retinoic acid, Device: LaserOne area will be treated |
| Subjects with alopecia-- area un-treated | Experimental | Drug: Sham treatment, Device: Sham treatmentOne area will be un-treated |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinoic acidThe study team will treat skin with topical retinoic acid | Drug | Subjects with alopecia-- area treated |
| LaserThe study team treat skin with a surface laser. | Device | Subjects with alopecia-- area treated |
| Sham treatmentNo drug will be given | Drug | Subjects with alopecia-- area un-treated |
| Sham treatmentNo laser treatment will be given | Device | Subjects with alopecia-- area un-treated |
Primary outcome
Change in Number of New Hairs
Time frame: baseline and 9 weeks post treatment (up to 6 months of treatment)
Change in number of new hairs, as assessed by manual counts using ImageJ dermatoscopic images
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Garza, MD/PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Retinoic acid and Laser in people with Central Centrifugal Cicatricial Alopecia (CCCA), run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of New Hairs (time frame: baseline and 9 weeks post treatment (up to 6 months of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.