Frontal Fibrosing AlopeciaPhase 2NCT05332366
A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
A Phase 2 study testing Delgocitinib cream in people with Frontal Fibrosing Alopecia, run by LEO Pharma at 1 site in United States.
Trial summary
This purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing the FFA disease signature in active lesions. The trial also investigated the clinical effect of delgocitinib cream on FFA compared to a placebo cream. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frontal Fibrosing Alopecia
- What is being tested?
- Delgocitinib cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 22 May 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Group 1 only (subjects with FFA):
- Male or female subject aged 18 years of age or older at the time of consent.
- Subject has clinically confirmed diagnosis of FFA.
- Subject has a target area with a perifollicular erythema score ≥ 2 and a perifollicular scale score ≥ 2 at Screening and Day 1.
- For Group 2 only (healthy subjects):
- Female subject aged 45 years of age or older at the time of consent.
- Female is postmenopausal.
- Subject is in good general health.
Who cannot join
- For all subjects:
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
- Presence of hepatitis B or C infection or HIV infection at screening.
- For Group 1 only (subjects with FFA):
- History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia.
- Subject who has undergone scalp reduction surgery or hair transplantation.
Show all 14Show fewer
- Subject is known to have immune deficiency or is immunocompromised.
- Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization.
- Subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization.
- Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to randomization.
- Subject has received any phototherapy within 4 weeks prior to randomization.
- For Group 2 only (healthy subjects):
- Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
- Subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
LEO Investigational Site
Burlington, Massachusetts, 01805
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled, Single Site, Exploratory Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
This purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing the FFA disease signature in active lesions. The trial also investigated the clinical effect of delgocitinib cream on FFA compared to a placebo cream.
- Conditions
- Frontal Fibrosing Alopecia
- Being tested
- Delgocitinib cream, Delgocitinib cream vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delgocitinib creamDrug
Also called LEO 124249 cream
Cream for topical application
Delgocitinib cream vehicleDrug
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Delgocitinib - Delgocitinib | Experimental | Participants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks. Receives: Drug: Delgocitinib cream |
| Placebo - Delgocitinib | Placebo comparator | Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks. Receives: Drug: Delgocitinib cream; Drug: Delgocitinib cream vehicle |
| No treatment | No intervention | Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12.
CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.
Measured: Baseline and Week 12
Secondary outcomes (1)
Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12.
Treatment emergent adverse events (TEAEs) were defined as any AEs with onset date on or after the first study treatment dosing.
Measured: Between baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start19 Apr 2022
- Primary completion13 Feb 2023
- Study completion22 May 2023
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Translational Medical Leader, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332366
- Sponsor's protocol ID
- EXP-2228
- Status last verified
- Feb 2025
- First submitted
- 11 Apr 2022
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled, Single Site, Exploratory Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
- ClinicalTrials.gov ID
- NCT05332366
- Acronym / sponsor ID
- EXP-2228
- Conditions
- Frontal Fibrosing Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing the FFA disease signature in active lesions. The trial also investigated the clinical effect of delgocitinib cream on FFA compared to a placebo cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delgocitinib - Delgocitinib | Experimental | Drug: Delgocitinib creamParticipants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks. |
| Placebo - Delgocitinib | Placebo comparator | Drug: Delgocitinib cream, Drug: Delgocitinib cream vehicleParticipants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks. |
| No treatment | No intervention | –Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject aged 18 years of age or older at the time of consent.
- Subject has clinically confirmed diagnosis of FFA.
- Subject has a target area with a perifollicular erythema score ≥ 2 and a perifollicular scale score ≥ 2 at Screening and Day 1.
- Female subject aged 45 years of age or older at the time of consent.
- Female is postmenopausal.
Key exclusion criteria (14 listed)
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
- Presence of hepatitis B or C infection or HIV infection at screening.
- History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia.
- Subject who has undergone scalp reduction surgery or hair transplantation.
- Subject is known to have immune deficiency or is immunocompromised.
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 |
|---|---|---|
| Delgocitinib creamAlso: LEO 124249 creamCream for topical application | Drug | Delgocitinib - Delgocitinib, Placebo - Delgocitinib |
| Delgocitinib cream vehicleThe cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. | Drug | Placebo - Delgocitinib |
Primary outcome
Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12.
Time frame: Baseline and Week 12
CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.
1 secondary outcome
Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12.
Time frame: Between baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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: No
Related trials for Frontal Fibrosing Alopecia
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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.
Translational Medical Leader study director
LEO Pharma
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 cream in people with Frontal Fibrosing Alopecia, run by LEO Pharma 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 14 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 6 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 7 Feb 2025). 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 Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12. (time frame: Baseline and Week 12). 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 NCT05332366, 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 6 Mar 2025.