Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.

Alopecia Areata Clinical Trial

Official title:

Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03325296
• Other study ID #: EXP-1377
• Secondary ID: 2017-002720-24
• Status: Terminated
• Phase: Phase 2
• Start date: October 30, 2017
• Est. completion date: May 16, 2018

Study information

• Verified date: July 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis), on both scalp and eyebrows as assessed by the investigator.

• Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening.

• Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.

Exclusion Criteria:

• Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator.

• Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo.

• Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation.

• Any biologic medicinal product targeting the immune system within 5 half-lives and minimum 4 weeks prior to randomisation (e.g. anti-TNFa, anti-IL17, anti IL12/23, anti IL-4Ra targeting drugs).

• Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• LEO 124249
Ointment containing LEO 124249

Other:
• Ointment vehicle
Ointment without active ingredients

Locations

Country	Name	City	State
Denmark	Investigational site	Aarhus
Denmark	Investigational site	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.	The percentage area of the identified left and right eyebrow area and left and right region of interest (ROI) covered by hair growth will be scored according to the following: 1-10 % - 1 11-20 % - 2 21-30 % - 3 31-40 % - 4 41-50 % - 5 51-60 % - 6 61-70 % - 7 71-80 % - 8 81-90 % - 9 91-100 % - 10	baseline to week 12
Secondary	Treatment emergent AEs (including AEs relating to local tolerability)		baseline to week 12
Secondary	Degree of response in change from baseline to Week 12 for ASoverall L+R	Complete response - = 8 Partial response - 4-<8 Minimal response - 1-<4 No response - <1	baseline to Week 12
Secondary	Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score	Is the appearance of the eyebrows cosmetically normal and acceptable? Yes - 1 No - due to insufficient regrowth area - 2 No - due to insufficient density - 3 No - due to uneven distribution - 4 No - due to other reason (explain, including combination of the above) - 5	baseline to Week 12