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

Phase 2

Completed

• Conditions: Frontal Fibrosing Alopecia
• Interventions: Drug: Delgocitinib cream; Drug: Delgocitinib cream vehicle

• Registration Number: NCT05332366
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-18
• Study Start: 2022-04-19
• Primary Completion: 2023-02-13
• Study Completion: 2023-05-22
• Disposition First Submitted: 2024-02-12
• Results First Submitted: 2024-10-09
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-06
• Results First Posted: 2025-02-07
• Disposition First Posted: 2025-02-07
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo - Delgocitinib	Delgocitinib cream vehicle	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.
Placebo - Delgocitinib	Delgocitinib cream	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 - Delgocitinib	Delgocitinib cream	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.

Primary Outcome Measures

Name	Time	Method
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.	Baseline and Week 12	CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.

Secondary Outcome Measures

Name	Time	Method
Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12.	Between baseline and Week 12	Treatment emergent adverse events (TEAEs) were defined as any AEs with onset date on or after the first study treatment dosing.

Trial Locations

Locations (1)

LEO Investigational Site; 🇺🇸 Burlington, Massachusetts, United States