LEO 124249 Ointment in the Treatment of Alopecia Areata

NCT02561585 | Completed Phase 2 Results

• 1 other identifier: EXP-1222
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Alopecia Areata Tool (SALT) Score

  The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.

  From baseline (Day 1) to Week 12 (Day 84)

Secondary Outcomes (13)

• Summary of Absolute SALT Score

  At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)

• Summary of Change in SALT Score

  From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)

• Summary of Relative Change in SALT Score

  From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)

• Percentage of Patients Who Achieve 50% Improvement in the SALT Score

  At Week 12 (Day 84)

• Hair Length

  At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)

Study Arms (2)

LEO 124249

EXPERIMENTAL

LEO 124249 ointment 30 mg/g twice daily

Drug: LEO 124249

Vehicle

PLACEBO COMPARATOR

LEO 124249 ointment vehicle twice daily

Other: Vehicle

Interventions

LEO 124249 DRUG

Also known as: LEO 124249 Ointment

LEO 124249

Vehicle OTHER

Also known as: LEO 124249 Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial.
• Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1, baseline).
• Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time limit.
• Subject must accept to not cut hair in the treated scalp areas during the trial.

You may not qualify if:

• Females who are pregnant or are breast feeding.
• Current signs of spontaneous hair regrowth.
• Diffuse type alopecia areata.
• Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and Ludwig stage II and III)
• Subjects with changed or expected changes in medication for thyroid disease within 6 month before Visit 1 (screening) or during the trial.
• Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Northwestern University

Evanston, Illinois, 60208, United States

Location

The Icahn School of Medicine, Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Emma Guttman, MD, PhD

  The Icahn School of Medicine, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 28, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 6, 2025
• Results First Posted: April 16, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)