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    Summary
    EudraCT Number:2016-003208-30
    Sponsor's Protocol Code Number:RAAINBOW
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2016-003208-30
    A.3Full title of the trial
    Double-blind, vehicle-controlled, randomized, 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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to investigate the efficacy and safety of LH-8 as a treatment for moderate to severe Alopecia Areata in children and adolescents
    A.4.1Sponsor's protocol code numberRAAINBOW
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/145/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLegacy Healthcare (France) SAS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLegacy Healthcare (France) SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLegacy Healthcare (France) SAS
    B.5.2Functional name of contact pointClinical Operations Director
    B.5.3 Address:
    B.5.3.1Street Address27 avenue de l’Opéra
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75001
    B.5.3.4CountryFrance
    B.5.4Telephone number4121552 2172
    B.5.5Fax number4121653 4484
    B.5.6E-maila.guichard@legacyhealthcare.ch
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLH-8
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot established
    D.3.9.3Other descriptive nameLIQUID ETHANOLIC EXTRACT 30 PER CENT (W/W) OF ALLIUM CEPA FRESH BULB AND CITRUS LIMON FRESH FRUIT
    D.3.9.4EV Substance CodeSUB184972
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2225
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot established
    D.3.9.3Other descriptive nameDRY HYDROETHANOLIC EXTRACT OF THEOBROMA CACAO SEED
    D.3.9.4EV Substance CodeSUB184973
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.010
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot established
    D.3.9.3Other descriptive nameDRY AQUEOUS EXTRACT OF PAULLINIA CUPANA SEED
    D.3.9.4EV Substance CodeSUB184974
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.010
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous solution
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alopecia Areata
    E.1.1.1Medical condition in easily understood language
    Hair loss on the scalp due to Alopecia Areata
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001761
    E.1.2Term Alopecia areata
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the therapeutic efficacy of a 24-week regimen of administration of LH-8 cutaneous solution twice daily, in children and adolescents (2 to less than 18 years) with chronic moderate-to-severe scalp alopecia areata.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy, safety and tolerability of LH-8 cutaneous solution, including the ocular irritant potential and non-irritant potential on skin.
    • To assess quality of life, acceptability and tolerability through self-evaluation as well as parental evaluation
    • To evaluate duration of the treatment effect after 6 months of treatment-free period.
    • To assess the treatment effect on hair follicles in non-alopecic areas.
    • To assess the rate of spontaneous remission in placebo treated patients whose alopecia areata has been active for 6-12 months compared with those whose alopecia areata has been active for greater than 12 months.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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 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 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. a relative or a 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
    E.5 End points
    E.5.1Primary end point(s)
    Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment (Visual assessment and global standardised scalp photographs for SALT evaluation).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 weeks of treatment
    E.5.2Secondary end point(s)
    Key secondary efficacy endpoints
    • Absolute change in SALT score from baseline at the end of 24 weeks’ treatment period.
    • 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.

    Other secondary endpoints
    • Adverse events
    • General physical examination findings, including irritation of eyes and skin
    • Evaluation of duration of treatment effect in responders, measured as relative SALT score changes 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).
    • Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas.
    • Assessment of the rate of spontaneous hair regrowth in placebo treated 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).
    • Absolute and relative change from baseline in CDLQI scores.
    • Change in percentage of subjects from baseline by the severity banding CDLQI scores.
    • Percentages of subjects by EQ-5D-Y dimensions and levels at Visits 1-5.
    • Absolute and relative change of the EQ-VAS scores from baseline.
    • Evaluation of the PAAPBI scores at Visits 1-5.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Either after 24 weeks of Treatment or 24 weeks after end of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 102
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 51
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 51
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-06-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 102
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects will be treated according to local standard practice.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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