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    Summary
    EudraCT Number:2009-018191-34
    Sponsor's Protocol Code Number:FOL003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-13
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2009-018191-34
    A.3Full title of the trial
    A Study to Explore the Effect of Controlled Cutaneous Perturbation and Pharmacologic Modulation for Inducing Follicular Neogenesis
    A.3.2Name or abbreviated title of the trial where available
    Lithium gluconate in hair follicle regrowth
    A.4.1Sponsor's protocol code numberFOL003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFollica Inc.
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name LITHIODERM 8% Gel
    D.2.1.1.2Name of the Marketing Authorisation holderLABCATAL
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 35941970
    D.3.9.3Other descriptive nameLITHIUM GLUCONATE
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeLithium containing gel for treatment of seborrheic dermatitis
    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 placeboGel
    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
    Male subjects with androgenetic alopecia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10068168
    E.1.2Term Androgenetic alopecia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary: To compare changes from Baseline to Day 84 in the number
    of photographically detected hairs in subjects treated with
    controlled cutaneous perturbation using dermabrasion (DA –
    a more superficial perturbation) plus the topical application of
    lithium gluconate 8% gel, to those subjects treated with
    controlled cutaneous perturbation plus the topical application
    of placebo gel.
    E.2.2Secondary objectives of the trial
    Secondary:
    1) To compare the changes from Baseline to Day 168 in the number of photographically detected hairs in subjects treated with controlled cutaneous perturbation using dermabrasion (DA) plus the topical application of lithium
    gluconate 8% gel, to those treated with controlled cutaneous perturbation plus the topical application of placebo gel;
    2) To compare the number of histologically detected neogenic-like hair follicles in biopsies taken on Day 14 from subjects treated with controlled cutaneous perturbation using dermabrasion (DA) plus topical lithium gluconate 8% gel, to those from subjects treated with dermabrasion plus topical placebo gel;
    3) To compare the number of histologically detected hair follicles in biopsies taken on Day 168 from subjects treated with controlled cutaneous perturbation using a
    4 mm punch biopsy (BX – a deeper perturbation) plus topical lithium gluconate 8% gel, to those from subjects treated with a 4 mm punch biopsy plus topical placebo gel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be able to understand the consent;
    2. Sign and date the written informed consent form prior to any study-related activity;
    3. Be Caucasian male subjects aged between 20 and 65 years of age who have;
    a. androgenetic alopecia with the presence of a vertex transition zone defined as an
    area possessing both normal and miniaturized hairs, Hamilton Norwood type 3V,
    4, 5, 5A or 5V with a vertex area large enough to accommodate all 3 treatment sites; and
    b. a Fitzpatrick skin type 1-4 (higher Fitzpatrick skin type ratings are excluded from
    the trial due to the increased risk of keloid formation and hypopigmentation in
    these subjects);
    4. Be willing and able to comply with the study procedures;
    5. Have no foreseeable reason to prevent completion of the study;
    6. Be willing to cover the head with a hat or similar protection during exposure to sun;
    7. Agree not to take 5-alpha-reductase inhibitors, such as finasteride (PROPECIA), at any time throughout the duration of this clinical study.
    E.4Principal exclusion criteria
    1. Participation in another clinical trial within the 30 days directly preceding the study, or earlier participation in the study;
    2. Simultaneous participation in another clinical trial;
    3. Any suspicion of drug and/or alcohol abuse;
    4. A clinical history suggestive of intolerance, allergies or idiosyncrasies to the study drug(s) or the ingredients of the product(s), or to agents that may be used in any of the trial procedures;
    5. A psychiatric condition that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing;
    6. Is an employee of the study site or of the Sponsor’s company;
    7. Any disease or circumstances on account of which the subject should not participate in the study in the opinion of the investigator. This includes any clinically significant medical condition that may interfere with the interpretation of the study results, including an uncontrolled chronic disease including, but not exclusive of, history of clinically significant diseases e.g. cardiovascular, haematological, endocrine, hepatic, renal, immunodeficiency disorder, coagulation abnormalities or malignancy.
    Specific exclusions:
    8. Female hair pattern (female pattern alopecia)
    9. History of keloids or hypertrophic scarring;
    10. History of poor wound healing;
    11. History of diabetes mellitus;
    12. History of coagulopathy/bleeding diathesis;
    13. History of hypersensitivity to lidocaine
    14. Immune compromise or undergoing therapy to treat an immune disorder;
    15. Serum creatinine, blood urea nitrogen (BUN) or HGB-A1C above the upper limits of normal (ULN), clinically significant abnormalities in liver function tests (3 times the upper limit of normal); gamma glutamyl transpeptidase (GGT), alkaline phosphatase, aspartate aminotransferase (AST) or alanine aminotransferase (ALT); or the presence of proteinuria (greater than a trace on urine dipstick); results to be confirmed by Day -14. All these values are based on the ULN for the laboratory performing the safety labs;
    16. Clinically significant abnormalities in vital signs or ECG results, in the opinion of the
    investigator;
    17. HIV, hepatitis B, hepatitis C positivity (negative status for each must be confirmed by Day -14);
    18. Diagnosis of any active skin condition that would interfere with study procedures or
    evaluations;
    19. Sunburned skin;
    20. Previous hair transplant surgery;
    21. Current or recent use (within preceding 6 months) of isoretinoin (ROACCUTANE);
    22. Current or recent use (within preceding 6 months) of minoxidil (ROGAINE);
    23. Unwillingness to abstain from the personal use of hair dye from the start of screening through and including the last study visit;
    24. Started, stopped, changed dose or changed regimen of 5 alpha reductase inhibitors, such as finasteride (PROPECIA), within the preceding 12 months;
    25. Current or recent use (within preceding 30 days) of hormone therapy, corticosteroids (except inhaled steroids or topical steroids to non-scalp areas) or other
    immunomodulators;
    26. Current or recent use (within preceding 30 days) of any lithium-containing product;
    27. Current or recent use (within preceding 14 days) of an anticoagulant or antiplatelet agent, including acetylsalicylic acid.
    28. Current or recent use (within preceding 30 days) of caffeine containing shampoo or other treatments applied to scalp to increase hair growth.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: The change from Baseline to Day 84 in the number of hairs
    captured by photography in the Target Analysis Area (DA – a
    more superficial perturbation).

    Secondary endpoint:
    1) the change from Baseline to Day 168 in the number of hairs captured by photography in the Target Analysis Area (DA);
    2) the number of neogenic-like hair follicles detected histologically in a first skin punch biopsy taken 14 days after the dermabrasion and topical treatment (Day 14);
    3) the number of hair follicles detected histologically in a second skin punch biopsy, which is taken approximately 5.5 months after the first biopsy (Day 168), at the site of
    the first biopsy (BX – a deeper perturbation) that was
    allowed to heal by secondary intention.

    Exploratory Efficacy, and Safety and PK Endpoints:
    1) the number of hairs captured by photography in the Circular Biopsy Area (BX) a) at Day 84 and b) at Day 168;
    2) the hair shaft thickness captured by photography a) at Day 84 and b) at Day 168 in the Circular Biopsy Area (BX);
    3) the difference in hair shaft thickness captured by photography a) from Baseline to Day 84 and b) from Baseline to Day 168 in the Target Analysis Area (DA);
    4) the histological characteristics in a second skin punch biopsy on Day 168;
    5) clinical evaluation using the Vancouver Scar Scale (VSS) on Day 84 and Day 168, versus Baseline;
    6) photographic evaluation of scar attributes on Day 84 and Day 168, versus Baseline.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    End of study is the last visit of the last subject.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    No treatment or care is planned after the subject has ended his participation in the trial.
    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 Decision2010-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-22
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