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The ONLY formal Follica clinical trial that we have proof of


#1

This is the only real information we have on any Follica clinical trials… from their trial a few years ago in Germany. There is NO evidence of any subsequent clinical trials happening after this, and no evidence of any Follica clinical trials in the US. So when they talk about “trials”, this is the only thing they can point to. ONE clinical trial in Germany, with uncertain results, in which the actual data was never reported to the public.

Summary
EudraCT Number: 2009-018191-34
Sponsor’s Protocol Code Number: FOL003
National Competent Authority: Germany - BfArM
Clinical Trial Type: EEA CTA
Trial Status: Ongoing

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 COUNTR(IES) CONCERNED
P. END OF TRIAL

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A. Protocol Information
A.1 Member State Concerned Germany - BfArM
A.2 EudraCT number 2009-018191-34
A.3 Full title of the trial A Study to Explore the Effect of Controlled Cutaneous Perturbation and Pharmacologic Modulation for Inducing Follicular Neogenesis

A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language
A.3.2 Name or abbreviated title of the trial where available Lithium gluconate in hair follicle regrowth

A.4.1 Sponsor’s protocol code number FOL003
A.7 Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8 EMEA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1 Name of Sponsor Follica Inc.
B.1.3.4 Country United States
B.3.1 and B.3.2 Status of the sponsor Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1 Name of organisation providing support
B.4.2 Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1 Name of organisation
B.5.2 Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3 IMP Role Test
D.2 Status of the IMP to be used in the clinical trial
D.2.1 IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1 Trade name LITHIODERM 8% Gel
D.2.1.1.2 Name of the Marketing Authorisation holder LABCATAL
D.2.1.2 Country which granted the Marketing Authorisation France
D.2.5 The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1 Orphan drug designation number
D.3 Description of the IMP
D.3.4 Pharmaceutical form Gel
D.3.4.1 Specific paediatric formulation Information not present in EudraCT
D.3.7 Routes of administration for this IMP Cutaneous use
Topical use (Noncurrent)

D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1 CAS number 35941970
D.3.9.3 Other descriptive name LITHIUM GLUCONATE
D.3.10 Strength
D.3.10.1 Concentration unit % (W/W) percent weight/weight
D.3.10.2 Concentration type equal
D.3.10.3 Concentration number 8
D.3.11 The IMP contains an:
D.3.11.1 Active substance of chemical origin Yes
D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3 Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1 Somatic cell therapy medicinal product No
D.3.11.3.2 Gene therapy medical product No
D.3.11.3.3 Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5 Radiopharmaceutical medicinal product No
D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7 Plasma derived medicinal product No
D.3.11.8 Extractive medicinal product No
D.3.11.9 Recombinant medicinal product Information not present in EudraCT
D.3.11.10 Medicinal product containing genetically modified organisms No
D.3.11.11 Herbal medicinal product No
D.3.11.12 Homeopathic medicinal product No
D.3.11.13 Another type of medicinal product Yes
D.3.11.13.1 Other medicinal product type Lithium containing gel for treatment of seborrheic dermatitis

D8. Information on Placebo
D.8 Placebo: 1
D.8.1 Is a Placebo used in this Trial? Yes
D.8.3 Pharmaceutical form of the placebo Gel
D.8.4 Route of administration of the placebo Topical use (Noncurrent)

E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1 Medical condition(s) being investigated Male subjects with androgenetic alopecia

MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2 Version 12.1
E.1.2 Level LLT
E.1.2 Classification code 10068168
E.1.2 Term Androgenetic alopecia

E.1.3 Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1 Main 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.2.2 Secondary 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.2.3 Trial contains a sub-study No
E.3 Principal 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.4 Principal 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.5.1 Primary 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.6 Scope of the trial
E.6.1 Diagnosis No
E.6.2 Prophylaxis No
E.6.3 Therapy No
E.6.4 Safety Yes
E.6.5 Efficacy Yes
E.6.6 Pharmacokinetic Yes
E.6.7 Pharmacodynamic No
E.6.8 Bioequivalence No
E.6.9 Dose response No
E.6.10 Pharmacogenetic No
E.6.11 Pharmacogenomic No
E.6.12 Pharmacoeconomic No
E.6.13 Others No
E.7 Trial type and phase
E.7.1 Human pharmacology (Phase I) No
E.7.1.1 First administration to humans No
E.7.1.2 Bioequivalence study No
E.7.1.3 Other No
E.7.2 Therapeutic exploratory (Phase II) Yes
E.7.3 Therapeutic confirmatory (Phase III) No
E.7.4 Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1 Controlled Yes
E.8.1.1 Randomised Yes
E.8.1.2 Open No
E.8.1.3 Single blind No
E.8.1.4 Double blind Yes
E.8.1.5 Parallel group Yes
E.8.1.6 Cross over No
E.8.1.7 Other No
E.8.2 Comparator of controlled trial
E.8.2.1 Other medicinal product(s) No
E.8.2.2 Placebo Yes
E.8.2.3 Other 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.8.4.1 Number of sites anticipated in Member State concerned 2
E.8.5 The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1 Trial being conducted both within and outside the EEA No
E.8.6.2 Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7 Trial 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.8.9.1 In the Member State concerned years 1
E.8.9.1 In the Member State concerned months 0
E.8.9.1 In the Member State concerned days 0
E.8.9.2 In all countries concerned by the trial years 0
E.8.9.2 In all countries concerned by the trial months 0
E.8.9.2 In all countries concerned by the trial days 0

F. Population of Trial Subjects
F.1 Age Range
F.1.1 Trial has subjects under 18 No
F.1.1.1 In Utero No
F.1.1.2 Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3 Newborns (0-27 days) No
F.1.1.4 Infants and toddlers (28 days-23 months) No
F.1.1.5 Children (2-11years) No
F.1.1.6 Adolescents (12-17 years) No
F.1.2 Adults (18-64 years) Yes
F.1.3 Elderly (>=65 years) No
F.2 Gender
F.2.1 Female No
F.2.2 Male Yes
F.3 Group of trial subjects
F.3.1 Healthy volunteers Yes
F.3.2 Patients No
F.3.3 Specific vulnerable populations No
F.3.3.1 Women of childbearing potential not using contraception No
F.3.3.2 Women of child-bearing potential using contraception No
F.3.3.3 Pregnant women No
F.3.3.4 Nursing women No
F.3.3.5 Emergency situation No
F.3.3.6 Subjects incapable of giving consent personally No
F.3.3.7 Others No
F.4 Planned number of subjects to be included
F.4.1 In the member state 62
F.4.2 For a multinational trial
F.4.2.1 In the EEA 0
F.4.2.2 In 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 countr(ies) concerned
N. Competent Authority Decision Authorised
N. Date of Competent Authority Decision or Application withdrawal 2010-05-18
N. Ethics Committee Opinion of the trial application Favourable
N. If an unfavorable opinion or withdrawal, give reasons for the unfavorable opinion/withdrawal
N. Date of Ethics Committee Opinion or Application withdrawal 2010-07-21

P. End of Trial
P. End of Trial Status


#2

There must have been more because they refer to trials with an “s” and that means plural/multiple trials.

That aside Roger, I’m sick of Follica. I feel like they probably have some herky-jerky technology that works a little sometimes but never works well. I think that Dr. Nigam experiments with stem cells, progenitor cells, 3d spheroids and microfollicles looks more promising right now.

I think they have already proved that done right 3d spheroids and microfollicles can produce new hair, and possibly stem/progenitor cells can too, but the thing is that this is very complex technology and how would Dr. Nigam be able to get it done in a way that would be cost-effective???


#3

Should be basically conclude that Follica haven’t and aren’t doing clinical trials, and that the media announcements are just hollow hype to pull in investment?


#4

The only one that we know of, that does not necessarily mean that they haven’t done other trials.