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

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ClinicalTrials.gov Identifier: NCT03325296
Recruitment Status : Terminated (Futility)
First Posted : October 30, 2017
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: LEO 124249 Other: Ointment vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : May 16, 2018
Actual Study Completion Date : May 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LEO 124249 ointment 30 mg/g
Ointment to be applied on the eyebrow twice daily.
Drug: LEO 124249
Ointment containing LEO 124249

Placebo Comparator: LEO 124249 ointment vehicle
Ointment to be applied on the eyebrow twice daily.
Other: Ointment vehicle
Ointment without active ingredients




Primary Outcome Measures :
  1. Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth. [ Time Frame: baseline to week 12 ]

    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



Secondary Outcome Measures :
  1. Treatment emergent AEs (including AEs relating to local tolerability) [ Time Frame: baseline to week 12 ]
  2. Degree of response in change from baseline to Week 12 for ASoverall L+R [ Time Frame: baseline to Week 12 ]
    Complete response - ≥ 8 Partial response - 4-<8 Minimal response - 1-<4 No response - <1

  3. Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score [ Time Frame: baseline to Week 12 ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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-TNFα, anti-IL17, anti IL12/23, anti IL-4Rα targeting drugs).
  • Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325296


Locations
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Denmark
Investigational site
Aarhus, Denmark, 8000
Investigational site
Gentofte, Denmark, 2820
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Study Director LEO Pharma

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03325296     History of Changes
Other Study ID Numbers: EXP-1377
2017-002720-24 ( EudraCT Number )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical