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

Frontal Fibrosing Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332366
• Other study ID #: EXP-2228
• Status: Completed
• Phase: Phase 2
• Start date: April 19, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: February 2024
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 22, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Frontal Fibrosing Alopecia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	LEO Investigational Site	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in expression of chemokine (C-X-C motif) ligand 9 (CXCL9), chemokine (C-X-C motif) ligand 10 (CXCL10), and interferon (IFN)-? from baseline to Week 12.	CXCL9, CXCL10 and IFN-? are small proteins that act as chemical messengers, especially in the immune system.	Baseline and Week 12
Secondary	Number of treatment-emergent adverse events (TEAEs) from baseline to Week 12.		Between baseline and Week 12