Frontal Fibrosing AlopeciaPhase 2NCT07671157
Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)
A Phase 2 study testing Delgocitinib in people with Frontal Fibrosing Alopecia, run by Maryanne Makredes Senna at 1 site in United States.
Trial summary
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational study drug to learn whether the delgocitinib 20 mg/g cream works in treating a specific disease. "Investigational" means that the delgocitinib 20 mg/g cream is being studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frontal Fibrosing Alopecia
- What is being tested?
- Delgocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to 10 Oct 2027
- 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
- Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any trial-related procedures.
- Subjects must be willing to comply with all trial procedures and must be available for the duration of the trial.
- Male or female subject aged 18 years of age or older at the time of consent.
- Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.
- Subject has clinically confirmed diagnosis of FFA based on investigator judgment.
- Subject has a target area with moderate to severe perifollicular erythema and/or scale at Screening and Day 1.
- For subject who uses make-up, moisturizers, creams, lotions, cleansers, and/or sunscreens on the face, subject has used the same product brands/types for a minimum period of 4 weeks prior to Day 1, agrees not to change brand/type or frequency of use throughout the trial, agrees not to apply those products on the treated area during the trial, and agrees not to use make-up, moisturizers, creams, lotions, cleansers, and/or sunscreens on the face on the clinic visit days before the visit.
- Subject is willing to maintain a consistent hair style and hair style regimen, including shampoo and hair products (including hair dye, process, and timing to hair appointments), and to refrain from weaves or extensions throughout the course of the trial and for 4 weeks prior to Day 1. Note: Hair dying and shaving of scalp is allowed during the trial but not within 48 hours prior to a trial visit.
Who cannot join
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
- Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
- Subject has had excessive sun exposure or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the trial. Use of sunscreen products (except on treated areas for subjects in Cohort 1) and protective apparel are recommended when sun exposure cannot be avoided.
- History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia. Note: Subjects with lichen planopilaris/FFA overlap are not to be excluded.
- Presence of active dermatologic condition that might interfere with FFA diagnosis and/or interfere with the trial assessments such as seborrheic dermatitis, psoriasis, or telogen effluvium.
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- Subject who has undergone scalp reduction surgery or hair transplantation.
- Use of adhesive wigs during the trial.
- Subject is known to have immune deficiency or is immunocompromised.
- Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
- Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the trial.
- Subject has any clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of trial results.
- Subject has positive results for hepatitis B surface antigens (HBsAg), antibodies to hepatitis B core antigens (anti-HBc), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Subject has used treatment with agents (including natural products or nutritional supplement such as Viviscal, Nutrafol, and/or biotin) that may affect hair regrowth in the last 4 weeks prior to Day 1. Patients who have been on oral minoxidil or oral spironolactone for 6 or more months may continue these medications at the same doses.
- Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to Day 1.
- Subject has used systemic treatment with immunosuppressive/modulating medication or medication that could affect FFA (eg, corticosteroids, methotrexate, hydroxychloroquine, retinoids, calcineurin inhibitor, tetracyclines, pioglitazone, oral JAK inhibitor, or 5-α-reductase-inhibitors) within 4 weeks prior to Day 1. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed. Note: Standard doses of systemic antihistamines are allowed.
- Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, calcineurin inhibitors, phosphodiesterase-4 (PDE-4) inhibitors, topical JAK inhibitors.
- Subject has received any ultraviolet (UV)-B phototherapy (including tanning beds), excimer laser, or any other phototherapy within 4 weeks prior to Day 1.
- Subject has had psoralen-UV-A (PUVA) treatment within 4 weeks prior to Day 1.
- Subject has a known or suspected allergy to delgocitinib or any component of the IMP.
- Subject has a history of an allergic reaction or significant sensitivity to hypoallergenic ink.
- Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
- Subject has prior use of delgocitinib cream as treatment for frontal fibrosing alopecia.
- Subject has prior failure of adequate response of frontal fibrosing alopecia to a topical JAK inhibitor or oral JAK inhibitor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joseph Hunt contact
United States1 site
Lahey Clinic
Burlington, Massachusetts, 01805
Hunt, 7819991853, joseph.hunt@lahey.org
About this study
Official title: Phase 2 Open Label Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational study drug to learn whether the delgocitinib 20 mg/g cream works in treating a specific disease. "Investigational" means that the delgocitinib 20 mg/g cream is being studied.
- Conditions
- Frontal Fibrosing Alopecia
- Being tested
- Delgocitinib
- Keywords
- alopecia, hairloss, FFA, frontal fibrosing alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelgocitinibDrug
Everyone in this study receives the study drug (delgocitinib)
| Study group | Role | What they receive |
|---|---|---|
| study drug | Experimental | Not described Receives: Drug: Delgocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hairline measurements
Change in hairline measurements from baseline to Week 24. (ie, lateral canthus [right and left] to hairline, lower glabellar crease to hair line, top of frontalis muscle to hair line, and mid brow to hair line [right and left])
Measured: from 0 to 24 weeks
Secondary outcomes (1)
Frontal scalp haircounts
Change in frontal scalp hair counts in a tattooed target area by trichoscopy from baseline to Week 24 following topical application of delgocitinib cream 20 mg/g in subjects with FFA.
Measured: 0 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frontal Fibrosing AlopeciaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maryanne Makredes Senna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maryanne Makredes Senna, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671157
- Sponsor's protocol ID
- 20263043
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martin A, Shokrian N, Kelley KJ, Correa da Rosa J, Del-Duca E, Bissonnette R, Sorensen OE, Nielsen AB, Guttman-Yassky E, Senna MM. Randomized Controlled Trial of the Topical Jak Inhibitor Delgocitinib Cream in Patients with Frontal Fibrosing Alopecia. J Invest Dermatol. 2026 May;146(5):1265-1270.e7. doi: 10.1016/j.jid.2025.09.375. Epub 2025 Oct 14.
PubMed 41101628
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Open Label Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)
- ClinicalTrials.gov ID
- NCT07671157
- Acronym / sponsor ID
- 20263043
- Conditions
- Frontal Fibrosing Alopecia
- Keywords
- alopecia, hairloss, FFA, frontal fibrosing alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maryanne Makredes SennaUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 26 Jun 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 research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational study drug to learn whether the delgocitinib 20 mg/g cream works in treating a specific disease. "Investigational" means that the delgocitinib 20 mg/g cream is being studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study drug | Experimental | Drug: Delgocitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any trial-related procedures.
- Subjects must be willing to comply with all trial procedures and must be available for the duration of the trial.
- Male or female subject aged 18 years of age or older at the time of consent.
- Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.
- Subject has clinically confirmed diagnosis of FFA based on investigator judgment.
Key exclusion criteria (24 listed)
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
- Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
- Subject has had excessive sun exposure or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the trial. Use of sunscreen products (except on treated areas for subjects in Cohort 1) and protective apparel are recommended when sun exposure cannot be avoided.
- History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia. Note: Subjects with lichen planopilaris/FFA overlap are not to be excluded.
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 |
|---|---|---|
| DelgocitinibEveryone in this study receives the study drug (delgocitinib) | Drug | study drug |
Primary outcome
Hairline measurements
Time frame: from 0 to 24 weeks
Change in hairline measurements from baseline to Week 24. (ie, lateral canthus [right and left] to hairline, lower glabellar crease to hair line, top of frontalis muscle to hair line, and mid brow to hair line [right and left])
1 secondary outcome
Frontal scalp haircounts
Time frame: 0 to 24 weeks
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 26 Aug 2026.
- Background: PubMed 41101628Martin A, Shokrian N, Kelley KJ, Correa da Rosa J, Del-Duca E, Bissonnette R, Sorensen OE, Nielsen AB, Guttman-Yassky E, Senna MM. Randomized Controlled Trial of the Topical Jak Inhibitor Delgocitinib Cream in Patients with Frontal Fibrosing Alopecia. J Invest Dermatol. 2026 May;146(5):1265-1270.e7. doi: 10.1016/j.jid.2025.09.375. Epub 2025 Oct 14.
- Individual participant dataSharing planned: Undecided
Related trials for Frontal Fibrosing Alopecia
Recruiting
Facial Papules in Frontal Fibrosing Alopecia (FFA)
Frontal Fibrosing Alopecia
RecruitingPhase 2
Deucravacitinib in the Treatment of Cicatricial Alopecias
Central Centrifugal Cicatricial Alopecia, Frontal Fibrosing Alopecia
Not yet recruitingObservational study
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)
Frontal Fibrosing Alopecia, Cicatricial Alopecia
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.
Joseph Hunt contact
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 Delgocitinib in people with Frontal Fibrosing Alopecia, run by Maryanne Makredes Senna 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 8 inclusion and 24 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: opening soon, as of the sponsor's last update on 26 Aug 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 Maryanne Senna, MD (7817441375, Maryanne.M.Senna@lahey.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hairline measurements (time frame: from 0 to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07671157, which also lists 1 linked publication.
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 26 Aug 2026.