Central Centrifugal Cicatricial AlopeciaPhase 2NCT07508488
Deucravacitinib in the Treatment of Cicatricial Alopecias
A Phase 2 study testing Deucravacitinib in people with Central Centrifugal Cicatricial Alopecia and Frontal Fibrosing Alopecia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a prospective, open-label clinical trial, in which all participants will be treated with deucravacitinib for 48 weeks. Approximately 20 participants will be enrolled: 10 Central Centrifugal Cicatricial Alopecia (CCCA) and 10 Frontal Fibrosing Alopecia (FFA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia, Frontal Fibrosing Alopecia
- What is being tested?
- Deucravacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of any gender, age 18 years or older, at the time of informed consent at Screening
- Participants who are willing and able to adhere to the study visit schedule and comply with protocol requirements.
- Participant self-reports a history of at least 6 months of moderate-to-severe CA (FFA or CCCA). Diagnosis will be made clinically, and severity assessed with according to the FFASI32 ≥30 and/or CHLG ≥3.
- Participant has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening or within the last 12 months.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP (all female participants, regardless of whether or not they have experienced/reported menarche, are considered WOCBP unless they are permanently sterile or confirmed infertile). A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of <1%, during the intervention period and for at least 28 days after the last dose of study intervention. And if a WOCBP, must have a negative highly sensitive serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline performed before the first dose of study intervention.
- Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.
Who cannot join
- Participant's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
- Participant has a history of CA for > 5 years since the disease onset, severe fibrosing disease, or very rapid hair loss at screening.
- Participant has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening. Deucravacitinib in the Treatment of Cicatricial Alopecias October 23, 2025.
- Other scalp disease that may impact assessment (e.g., scalp psoriasis, dermatitis, etc.).
- Participant is pregnant or breastfeeding.
- Participation in other studies involving investigational drug(s) within 4 weeks or within 5 half-lives (if known), whichever is longer, prior to study entry and/or during study participation (de novo patients only).
Show all 28Show fewer
- Active systemic diseases that may cause hair loss (e.g., systemic lupus erythematosus, thyroiditis, systemic sclerosis, etc.).
- Any Psychiatric condition in the opinion of the investigator precludes participation in the study.
- Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly thyroid disease which can be associated with hair loss), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator, the participant is inappropriate for entry into this study, or unwilling/unable to comply with STUDY PROCEDURES.
- History of thromboembolic events including DVT and PE or history of inherited coagulopathies.
- Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
- History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 0.
- Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 0 or superficial skin infection within 1 week prior to Day 0. Deucravacitinib in the Treatment of Cicatricial Alopecias October 23, 2025.
- Considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
- Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening.
- Participant has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints, as determined by the PI.
- Have an active history of alcohol or substance abuse within 1 year prior to Day 0.
- Participant has received a live attenuated vaccine ≤ 6 weeks prior to study screening.
- History of adverse systemic or allergic reactions to components of study drug.
- Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, within 8 weeks prior to baseline visit.
- Use of other non-biologic systemic agent for CA, including, 5α-reductase inhibitors, hydroxychloroquine, or retinoids, within 4 weeks prior to baseline visit.
- Use of an intralesional corticosteroids or oral JAK inhibitor (tofacitinib, ruxolitinib, or any JAK1/TYK2 product) within 4 weeks prior to the baseline visit.
- Any previous use of a TYK2 inhibitor.
- Participant has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus or cyclosporine within 1 week before the baseline visit.
- Participant has been previously treated with biological drugs in the last 12 weeks for other indications.
- Participants previously tested with a positive or indeterminable PPD or QFT result, including participants that completed standard tuberculosis therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Giselle Singer, 212-241-3288, giselle.singer@mssm.edu
Benjamin Ungar
About this study
This is a prospective, open-label clinical trial, in which all participants will be treated with deucravacitinib for 48 weeks. Approximately 20 participants will be enrolled: 10 Central Centrifugal Cicatricial Alopecia (CCCA) and 10 Frontal Fibrosing Alopecia (FFA). The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS). At the Baseline/Day 0 visit, participants will initiate treatment with deucravacitinib. All participants will receive deucravacitinib 12mg once-daily for 48 weeks. The treatment period will conclude at week 48.
- Being tested
- Deucravacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
6mg twice-daily oral treatment for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Central Centrifugal Cicatricial Alopecia | Experimental | Contains individuals diagnosed with Central Centrifugal Cicatricial Alopecia. Receives: Drug: Deucravacitinib |
| Frontal Fibrosing Alopecia | Experimental | Contains individuals diagnosed with Frontal Fibrosing Alopecia. Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in IFNγ in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Baseline to Week 24
Changes in CCL5 in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Baseline to Week 24
Changes in CXCL9 in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Baseline to Week 24
Changes in CXCL10 in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Baseline to Week 24
Changes in TGFB1/2 in CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Baseline to Week 24
Changes in vimentin in CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Baseline to Week 24
Changes in fibronectin CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Baseline to Week 24
Changes in CTGF in CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Baseline to Week 24
Secondary outcomes (20)
Changes in IFNγ in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Week 24 to Week 48
Changes in CCL5 in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Week 24 to Week 48
Changes in CXCL9 in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Week 24 to Week 48
Changes in CXCL10 in CA scalp
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Week 24 to Week 48
Changes in TGFB1/2 in CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Week 24 to Week 48
Changes in vimentin in CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Week 24 to Week 48
Changes in fibronectin CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Week 24 to Week 48
Changes in CTGF in CA scalp
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Measured: Week 24 to Week 48
Change in The Central Hair Loss Grade (CHLG)
Change in CHLG from baseline at week 24 and week 48. The Central Hair Loss Grade is a clinical measure of severity that uses a 6 points scale (0 no central scalp hair loss, 1 - minimal central scalp hair loss, 2 - clinically evident central scalp hair loss, 3-5 advanced central scalp hair loss).
Measured: Baseline to Week 24; Baseline to Week 48
Change in Frontal Fibrosing Alopecia Severity Index (FFASI)
Change in FFASI from baseline at week 24 and week 48. The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline divided into 4 sections. Score from 1-5, with higher score indicating more severity.
Measured: Baseline to Week 24; Baseline to Week 48
Changes in mRNA Levels of CCL5 gene expression in skin biopsies
Evaluation of how the two skin conditions (CCCA and FFA) present themselves at the microscopic level. The skin samples will be obtained via biopsies.
Changes in mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 24. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene
Measured: baseline and week 24
Change in Alopecia Areata Quality of Life Index (AA-QLI)
Change in Alopecia Areata Quality of Life Index (AA-QLI) in week 24 and week 48. The scores range from 0 - 30 with 0 representing no impact to quality of life and 30 representing extremely large impact.
Measured: Week 24 and Week 48
Change in Peak Pruritus Numerical Rating Scale (PP-NRS)
Change in Peak Pruritus Numerical Rating Scale (PP-NRS) at week 24 and week 48. The score ranges from 0 - 10 with 0 representing no itch and 10 representing worse possible itch.
Measured: Week 24 and Week 48
Change in hair count per cm2
Change in number of hairs present in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48
Measured: Baseline to Week 24; Baseline to Week 48
Change in sum of hair width per cm2
Change in total hair diameter in a 2 cm2 area between Baseline to Week 24 and Baseline to Week 48
Measured: Baseline to Week 24; Baseline to Week 48
Change in terminal:vellus ratio
Change in the ratio of thick pigmented long hair to fine-barely visible hairs between Baseline to Week 24 and Baseline to Week 48
Measured: Baseline to Week 24; Baseline to Week 48
Change in average hairs per follicular unit
Change in hair density in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48
Measured: Baseline to Week 24; Baseline to Week 48
Change in average hair width
Change in average width of each individual hair between Baseline to Week 24 and Baseline to Week 48
Measured: Baseline to Week 24; Baseline to Week 48
Change in follicular units per cm2
Change in hair density in a 1 cm2 area between Baseline to Week 24 and Baseline to Week 48
Measured: Baseline to Week 24; Baseline to Week 48
Change in inter-follicular mean distance
Change in average gap between hairs using a diagnotic tool called the HairMetrix diagnostic tool that can accurately measure the interfollicular distance between baseline to Week 24 and baseline to Week 48
Measured: Baseline to Week 24; Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start28 May 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Centrifugal Cicatricial AlopeciaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open label
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Benjamin Ungar, Icahn School of Medicine at Mount Sinai
- Investigators
- Benjamin Ungar, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508488
- Sponsor's protocol ID
- STUDY-25-01566
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be analyzed and published as aggregate data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deucravacitinib in the Treatment of Cicatricial Alopecias
- ClinicalTrials.gov ID
- NCT07508488
- Acronym / sponsor ID
- STUDY-25-01566
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 28 May 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open-label clinical trial, in which all participants will be treated with deucravacitinib for 48 weeks. Approximately 20 participants will be enrolled: 10 Central Centrifugal Cicatricial Alopecia (CCCA) and 10 Frontal Fibrosing Alopecia (FFA). The study will take place at the Icahn School of Medicine at Mount Sinai (ISMMS). At the Baseline/Day 0 visit, participants will initiate treatment with deucravacitinib. All participants will receive deucravacitinib 12mg once-daily for 48 weeks. The treatment period will conclude at week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open label
| Arm | Type | Receives |
|---|---|---|
| Central Centrifugal Cicatricial Alopecia | Experimental | Drug: DeucravacitinibContains individuals diagnosed with Central Centrifugal Cicatricial Alopecia. |
| Frontal Fibrosing Alopecia | Experimental | Drug: DeucravacitinibContains individuals diagnosed with Frontal Fibrosing Alopecia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants of any gender, age 18 years or older, at the time of informed consent at Screening
- Participants who are willing and able to adhere to the study visit schedule and comply with protocol requirements.
- Participant self-reports a history of at least 6 months of moderate-to-severe CA (FFA or CCCA). Diagnosis will be made clinically, and severity assessed with according to the FFASI32 ≥30 and/or CHLG ≥3.
- Participant has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening or within the last 12 months.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP (all female participants, regardless of whether or not they have experienced/reported menarche, are considered WOCBP unless they are permanently sterile or confirmed infertile). A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of <1%, during the intervention period and for at least 28 days after the last dose of study intervention. And if a WOCBP, must have a negative highly sensitive serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline performed before the first dose of study intervention.
Key exclusion criteria (28 listed)
- Participant's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
- Participant has a history of CA for > 5 years since the disease onset, severe fibrosing disease, or very rapid hair loss at screening.
- Participant has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening. Deucravacitinib in the Treatment of Cicatricial Alopecias October 23, 2025.
- Other scalp disease that may impact assessment (e.g., scalp psoriasis, dermatitis, etc.).
- Participant is pregnant or breastfeeding.
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 |
|---|---|---|
| Deucravacitinib6mg twice-daily oral treatment for 48 weeks. | Drug | Central Centrifugal Cicatricial Alopecia, Frontal Fibrosing Alopecia |
Primary outcome
Changes in IFNγ in CA scalp
Time frame: Baseline to Week 24
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in CCL5 in CA scalp
Time frame: Baseline to Week 24
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in CXCL9 in CA scalp
Time frame: Baseline to Week 24
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in CXCL10 in CA scalp
Time frame: Baseline to Week 24
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in TGFB1/2 in CA scalp
Time frame: Baseline to Week 24
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in vimentin in CA scalp
Time frame: Baseline to Week 24
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in fibronectin CA scalp
Time frame: Baseline to Week 24
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in CTGF in CA scalp
Time frame: Baseline to Week 24
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
20 secondary outcomes
Changes in IFNγ in CA scalp
Time frame: Week 24 to Week 48
Changes in CCL5 in CA scalp
Time frame: Week 24 to Week 48
Changes in CXCL9 in CA scalp
Time frame: Week 24 to Week 48
Changes in CXCL10 in CA scalp
Time frame: Week 24 to Week 48
Changes in TGFB1/2 in CA scalp
Time frame: Week 24 to Week 48
Changes in vimentin in CA scalp
Time frame: Week 24 to Week 48
Changes in fibronectin CA scalp
Time frame: Week 24 to Week 48
Changes in CTGF in CA scalp
Time frame: Week 24 to Week 48
Change in The Central Hair Loss Grade (CHLG)
Time frame: Baseline to Week 24; Baseline to Week 48
Change in Frontal Fibrosing Alopecia Severity Index (FFASI)
Time frame: Baseline to Week 24; Baseline to Week 48
Changes in mRNA Levels of CCL5 gene expression in skin biopsies
Time frame: baseline and week 24
Change in Alopecia Areata Quality of Life Index (AA-QLI)
Time frame: Week 24 and Week 48
Change in Peak Pruritus Numerical Rating Scale (PP-NRS)
Time frame: Week 24 and Week 48
Change in hair count per cm2
Time frame: Baseline to Week 24; Baseline to Week 48
Change in sum of hair width per cm2
Time frame: Baseline to Week 24; Baseline to Week 48
Change in terminal:vellus ratio
Time frame: Baseline to Week 24; Baseline to Week 48
Change in average hairs per follicular unit
Time frame: Baseline to Week 24; Baseline to Week 48
Change in average hair width
Time frame: Baseline to Week 24; Baseline to Week 48
Change in follicular units per cm2
Time frame: Baseline to Week 24; Baseline to Week 48
Change in inter-follicular mean distance
Time frame: Baseline to Week 24; Baseline to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. Results will be analyzed and published as aggregate data.
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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.
Benjamin Ungar, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deucravacitinib in people with Central Centrifugal Cicatricial Alopecia and Frontal Fibrosing Alopecia, run by Icahn School of Medicine at Mount Sinai 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 6 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 10 Jul 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giselle Singer (2122413288, giselle.singer@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in IFNγ in CA scalp (time frame: Baseline to Week 24). The study lists 8 primary outcomes in all. 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 10 Jul 2026.