A Study to Explore the Effect of Controlled Cutaneous Perturbation and Pharmacologic Modulation for Inducing Follicular Neogenesis - Lithium gluconate in hair follicle regrowth

• Register: EUCTR
• Last refreshed on: 22 October 2012
• Main ID: EUCTR2009-018191-34-DE
• Date of registration: 13/04/2010
• Prospective Registration: Yes
• Primary sponsor: Follica Inc.
• Public title: A Study to Explore the Effect of Controlled Cutaneous Perturbation and Pharmacologic Modulation for Inducing Follicular Neogenesis - Lithium gluconate in hair follicle regrowth
• Scientific title: A Study to Explore the Effect of Controlled Cutaneous Perturbation and Pharmacologic Modulation for Inducing Follicular Neogenesis - Lithium gluconate in hair follicle regrowth
• Date of first enrolment: 21/07/2010
• Target sample size: 0
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018191-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Male subjects with androgenetic alopecia
MedDRA version: 12.1 Level: LLT Classification code 10068168 Term: Androgenetic alopecia

Intervention(s)

Trade Name: LITHIODERM 8% Gel
Pharmaceutical Form: Gel
CAS Number: 35941970
Other descriptive name: LITHIUM GLUCONATE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Topical use (Noncurrent)

Primary Outcome(s)

Main Objective: 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.

Secondary Objective: 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.

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.

Secondary ID(s)

FOL003