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

• Conditions: Male subjects with androgenetic alopecia; MedDRA version: 12.1Level: LLTClassification code 10068168Term: Androgenetic alopecia

• Registration Number: EUCTR2009-018191-34-DE
• Lead Sponsor: Follica Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-13
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified