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Efficacy and Safety of LH-8 in Paediatric Alopecia Areata (AA)

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ClinicalTrials.gov Identifier: NCT03240627
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Legacy Healthcare SA

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 and Romania in 100 patients.


Condition or disease Intervention/treatment Phase
Alopecia Areata Pediatric Disorder Drug: LH-8 Drug: Placebos Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.
Masking: Single (Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
Experimental: LH-8 cutaneous solution
LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp:
Drug: LH-8
LH-8 cutaneous solution
Placebo Comparator: Placebo cutaneous solution
Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp:
Drug: Placebos
Placebo cutaneous solution



Primary Outcome Measures :
  1. Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. [ Time Frame: 24 weeks treatment ]
    Visual assessment and global standardised scalp photographs for SALT evaluation.


Secondary Outcome Measures :
  1. Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]
  2. Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]
  3. Adverse events [ Time Frame: 48 weeks ]
  4. General physical examination findings, including irritation of eyes and skin [ Time Frame: 48 weeks ]
  5. Evaluation of duration of treatment effect in responders, measured as relative SALT score changes [ Time Frame: 48 weeks ]
    From Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. Visual assessment and global standardised scalp photographs for SALT evaluation.

  6. Assessment of treatment effect on hair follicles in non-alopecic areas [ Time Frame: 48 weeks ]
    By quantifying the number of new alopecic areas.

  7. Assessment of the rate of spontaneous hair regrowth in placebo treated subjects [ Time Frame: 48 weeks ]
    Subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation)

  8. Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores [ Time Frame: 48 weeks ]
  9. Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]
  10. Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1 to 5 [ Time Frame: 48 weeks ]
  11. Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]
  12. Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03240627


Contacts
Contact: Marie Cristina SANDRU, PhD :+ 49 724 512 881 msandru@scope-international.com
Contact: Alexandre GUICHARD, PharmD.,PhD + 41 789 344 815 a.guichard@legacyhealthcare.ch

Locations
Germany
Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin Recruiting
Berlin, Berlin,, Germany, 10117
Contact: Ulrike KZ Blume-Peytavi, Prof. MD.    ++49 30 450 518 122    Ulrike.blume-peytavi@charite.de   
Sponsors and Collaborators
Legacy Healthcare SA
Investigators
Principal Investigator: Ulrike BLUME-PEYTAVI, Prof. Dr. Charité-Universitätsmedizin Berlin, Dept Dermatology, Germany

Responsible Party: Legacy Healthcare SA
ClinicalTrials.gov Identifier: NCT03240627     History of Changes
Other Study ID Numbers: RAAINBOW
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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