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

NCT ID: NCT05332366

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2023-05-22

Brief 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.

Conditions

Frontal Fibrosing Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Delgocitinib cream

Intervention Type: DRUG

Cream for topical application

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.

Group Type: PLACEBO_COMPARATOR

Delgocitinib cream

Intervention Type: DRUG

Cream for topical application

Delgocitinib cream vehicle

Intervention Type: DRUG

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

No treatment

Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Delgocitinib cream

Cream for topical application

Intervention Type: DRUG

Delgocitinib cream vehicle

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Intervention Type: DRUG

Other Intervention Names

LEO 124249 cream

Eligibility Criteria

Inclusion Criteria

For Group 1 only (subjects with FFA):

1. Male or female subject aged 18 years of age or older at the time of consent.

2. Subject has clinically confirmed diagnosis of FFA.

3. 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):

1. Female subject aged 45 years of age or older at the time of consent.

2. Female is postmenopausal.

3. Subject is in good general health.

Exclusion Criteria

For all subjects:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.

2. Presence of hepatitis B or C infection or HIV infection at screening.

For Group 1 only (subjects with FFA):

1. History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia.

2. Subject who has undergone scalp reduction surgery or hair transplantation.

3. Subject is known to have immune deficiency or is immunocompromised.

4. Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization.

5. Subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization.

6. Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to randomization.

7. Subject has received any phototherapy within 4 weeks prior to randomization.

For Group 2 only (healthy subjects):

1. 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.

2. Subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Translational Medical Leader

Role: STUDY_DIRECTOR

LEO Pharma

Locations

LEO Investigational Site

Burlington, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EXP-2228

Identifier Type: -

Identifier Source: org_study_id