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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| No treatment | No Intervention | Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib cream | Drug | Cream for topical application |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between baseline and Week 12 |
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Inclusion criteria
For Group 1 only (subjects with FFA):
For Group 2 only (healthy subjects):
Exclusion criteria
For all subjects:
For Group 1 only (subjects with FFA):
For Group 2 only (healthy subjects):
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| Name | Affiliation | Role |
|---|---|---|
| Translational Medical Leader | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Investigational Site | Burlington | Massachusetts | 01805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41101628 | Derived | 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. |
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Eligible subjects were randomized into the trial after a screening period. They were assigned to receive either delgocitinib cream or a placebo twice daily for 12 weeks. After completing this period, they continued using delgocitinib cream for another 12 weeks.
The trial was conducted in the United States and consisted of 2 cohorts: Cohort 1 included 30 subjects with FFA and Cohort 2 included 5 healthy postmenopausal female subjects. Both cohorts were conducted in parallel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delgocitinib - Delgocitinib | 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. Delgocitinib cream: Cream for topical application |
| FG001 | Placebo - Delgocitinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2021 |
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| Delgocitinib cream vehicle | Drug | The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. |
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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. Delgocitinib cream: Cream for topical application Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. |
| FG002 | No Treatment | Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Delgocitinib - Delgocitinib | 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. Delgocitinib cream: Cream for topical application |
| BG001 | Placebo - Delgocitinib | 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. Delgocitinib cream: Cream for topical application Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. |
| BG002 | No Treatment | Participants did not receive any treatment. They will only provide a molecular signature of healthy skin to act as a control. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height (cm) | Mean | Standard Deviation | units on a scale |
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| Weight (kg) | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No data was collected for "No Treatment" Arm/Groups". | Posted | Number | Fold-changes | Baseline and Week 12 |
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| Secondary | 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. | No investigational product was administered in Cohort 2 "No Treatment" Arm/Groups" and thereby were no treatment-emergent AESIs reported in this trial for "No Treatment" Arm/Groups". | Posted | Number | events | Between baseline and Week 12 |
|
Baseline and week 12
No investigational product was administered for 'No Treatment' Arm/Groups; and thus collection of adverse events did not occur for the participants in this group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delgocitinib - Delgocitinib | 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. Delgocitinib cream: Cream for topical application | 0 | 15 | 0 | 15 | 6 | 15 |
| EG001 | Placebo - Delgocitinib | 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. Delgocitinib cream: Cream for topical application Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. | 0 | 15 | 0 | 15 | 10 | 15 |
| EG002 | No Treatment | Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 24.0 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Incision site rash | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Antinuclear antibody positive | Investigations | MedDRA 24.0 | Non-systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | Leo Pharma | +4544945888 | disclosure@leo-pharma.com |
| Sep 30, 2024 |
| Prot_SAP_000.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Interferon (IFN)-γ |
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