Back to resultsA Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
Primary Purpose
Frontal Fibrosing Alopecia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Delgocitinib cream
Delgocitinib cream vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Frontal Fibrosing Alopecia
Eligibility Criteria
Inclusion criteria
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.
Exclusion criteria
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.
- 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.
Sites / Locations
- LEO Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Delgocitinib - Delgocitinib
Placebo - Delgocitinib
No treatment
Arm Description
Participants will be 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.
Participants will be 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.
Participants will not receive any treatment. They will only provide a molecular signature of healthy skin to act as a control.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of treatment-emergent adverse events (TEAEs) from baseline to Week 12.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05332366
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
February 13, 2023 (Actual)
Study Completion Date
May 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This purpose of this trial is 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 will also investigate the clinical effect of delgocitinib cream on FFA compared to a placebo cream.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontal Fibrosing Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delgocitinib - Delgocitinib
Arm Type
Experimental
Arm Description
Participants will be 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.
Arm Title
Placebo - Delgocitinib
Arm Type
Placebo Comparator
Arm Description
Participants will be 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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Participants will not receive any treatment. They will only provide a molecular signature of healthy skin to act as a control.
Intervention Type
Drug
Intervention Name(s)
Delgocitinib cream
Other Intervention Name(s)
LEO 124249 cream
Intervention Description
Cream for topical application
Intervention Type
Drug
Intervention Name(s)
Delgocitinib cream vehicle
Intervention Description
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Primary Outcome Measure Information:
Title
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.
Description
CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Number of treatment-emergent adverse events (TEAEs) from baseline to Week 12.
Time Frame
Between baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria
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.
Exclusion criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Translational Medical Leader
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Investigational Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
IPD Sharing Time Frame
Data is available to request after results of the trial are available on leopharmatrials.com
IPD Sharing Access Criteria
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
IPD Sharing URL
http://leopharmatrials.com/for-professionals
Learn more about this trial
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
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