Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

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Brief Title

Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

Official Title

Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.

Brief Summary

      Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8
      cutaneous solution versus placebo in children and adolescents with moderate to severe scalp
      alopecia areata.

      Phase 2/3 study performed in Germany, Bulgaria , Romania and France in 100 patients.
    

Detailed Description

      Methods / trial design:

      Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.

      At screening (Visit 0), subjects will discontinue their previous treatment for alopecia
      areata, if any. Screening period will last up to 28 days. The 24-week treatment phase will
      include assessment Visits 1 to 3, which will take place at 12-week intervals. At assessment
      Visit 1, eligible subjects will be randomly assigned in a 2:1 ratio to receive LH-8 cutaneous
      solution or vehicle (placebo) twice daily for a 24 week treatment period. During the
      treatment phase the subjects will complete daily their drug diaries. The post-treatment
      safety and efficacy follow-up phase will include Visit 4 and Visit 5, 12 and 24 weeks after
      end of treatment, respectively.

      Subjects (as applicable) and parents will be instructed to contact the investigator, if an
      event on scalp (intolerance) occurs during the treatment or post-treatment period. They may
      be asked to come to the site for an unscheduled visit, in order to perform additional
      examinations.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment.

Secondary Outcome

 Absolute change in SALT score from baseline at the end of 24 weeks' treatment period.

Condition

Alopecia Areata

Intervention

LH-8

Study Arms / Comparison Groups

 LH-8 cutaneous solution
Description:  LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

March 1, 2018

Completion Date

June 1, 2021

Primary Completion Date

February 1, 2020

Eligibility Criteria

        Male and female children and adolescents aged 2 to less than 18 years with active alopecia
        areata involving 25% to 95% of the scalp between 6 months and 3 years in duration.

        Diagnosis and main criteria for inclusion: Male and female children and adolescents aged 2
        to less than 18 years with active alopecia areata involving 25% to 95% of the scalp between
        6 months and 3 years in duration.

        Inclusion criteria:

          1. Male and female children and adolescents aged 2 to less than 18 years.

          2. Active scalp alopecia areata, involving 25% to 95% of the scalp (as measured by SALT
             score at screening).

          3. Duration of hair loss between 6 months and 3 years.

          4. Female subjects of childbearing potential (postmenarcheal) must have a negative urine
             pregnancy test at screening. Females of childbearing potential must either not be
             sexually active or be using an adequate birth control method throughout the duration
             of the study.

          5. All subjects taking thyroid medication or hormonal therapy must be on a stable dose
             for 6 months and maintain such throughout the study.

          6. Subjects must be willing to maintain the same hair style, including hair dye,
             throughout the study period.

          7. Written informed consent signed by parent(s) or legally authorized representative and
             assent or consent signed by the subjects, if applicable, according to national
             regulations prior to any protocol specific procedures.

        Exclusion criteria:

          1. Hypersensitivity or intolerance to any active IMP substances (onion, citrus, caffeine,
             theobromine) or excipients (glycerine, betaine or ethanol).

          2. Any cause of hair loss other than alopecia areata.

          3. Active scalp inflammation except alopecia areata.

          4. Nevi, cutaneous or non-cutaneous lesions currently undiagnosed but suspicious for
             malignancy.

          5. Female adolescents who are pregnant or who are nursing or plan pregnancy during the
             trial period.

          6. Use of topical medication (listed in protocol Section 10.7.1) within 2 weeks prior to
             Visit 1.

          7. Use of systemic alopecia areata therapies (e.g. prednisone, cyclosporine,
             methotrexate), including use of these medications for other indications, and
             intralesional corticosteroids within 1 month prior to Visit 1.

          8. Administration of hydroxychloroquine or finasteride within two months prior to Visit
             1.

          9. Use of phototherapy, laser therapy or excimer laser therapy on the scalp within three
             months prior to Visit 1.

         10. Use of infliximab within two months, adalimumab within three months, and ustekinumab
             within four months prior to Visit 1 or use of other TNF inhibitors and biologic agents
             within one month or five half-lives before Visit 1, whichever is longer.

         11. Prior treatment with IMP.

         12. Evidence or history of alcohol, medication or drug abuse.

         13. History of systemic or cutaneous medical, or psychiatric disease which will put
             subject at risk or interfere with assessments.

         14. Participation in any other clinical trial within 30 days prior to Visit 1.

         15. Subject is in a dependent relationship (e.g. relative or family member) with the
             investigator's or sponsor's staff.

         16. Any other condition or circumstance that, in the opinion of the investigator, could
             compromise the subject's ability to comply with the study protocol.
      

Gender

All

Ages

2 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Ulrike BLUME-PEYTAVI, Prof. Dr., + 41 789 344 815, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03240627

Organization ID

RAAINBOW


Responsible Party

Sponsor

Study Sponsor

Legacy Healthcare SA


Study Sponsor

Ulrike BLUME-PEYTAVI, Prof. Dr., Study Chair, Charité-Universitätsmedizin Berlin, Dept Dermatology, Germany


Verification Date

November 2019