Microarray Analysis of Scalp Biopsies After Minoxidil Treatment

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.

Detailed Description
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The most common type of hair loss is androgenetic alopecia (AGA), also known as male pattern balding, or hereditary thinning. In AGA, there is a gradual transformation of large terminal hair follicles to miniaturized ones under the influence of circulating androgens that produce smaller and finer hairs with a shorter anagen cycle. This transformation, which can be seen as early as the prepubescent years, occurs only in certain regions of the scalp: the frontal hairline, top and vertex scalp. The temporo-occipital region is largely unaffected even in those with extensive balding. The first drug to be approved for the FDA for the treatment of AGA was topical minoxidil solution (TMS). Despite its successful use, the mechanism of action of TMS is not well understood. Minoxidil is a potent vasodilator and potassium channel opener, but its mechanism of action in promoting hair regrowth appears to be independent of its vasodilation properties. Improved knowledge of the changes in gene expression associated with AGA before and after treatment with TMS and compared to placebo may lead to a greater understanding of the underlying mechanisms of action of TMS. Furthermore, there is potential for identification of those patients who would best respond to or benefit from treatment.

Official Title
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Microarray Analysis of Scalp Biopsies in Subjects With Androgenetic Alopecia Before and After the Use of Topical Minoxidil

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Other: Minoxidil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a male Is in general good health Has a diagnosis of androgenic alopecia with hair loss in both the vertex and the frontal area, Hamilton (as modified by Norwood) Type IV-V Has read, signed and received a copy of the Informed Consent Form prior to initiation of the study procedures Is willing to follow all instructions and able to participate in the entire study, returning for all specified visits Between the age of 18 to 49 years old, inclusively Exclusion Criteria: Evidence of concomitant skin diseases of the scalp including but not limited to dandruff, seborrheic dermatitis, psoriasis, lichenoid eruption, tinea capitis or other scalp infections or infestations. Has a history of recurring dandruff symptoms or seborrheic dermatitis, evidence of excoriations, or other history that might indicate an inability to use the products supplied for the duration of the study. Has consistently used any medicated shampoos or anti-dandruff shampoo treatment products over the past year or at all during the two months prior to the Baseline visit. Has a history of alopecia areata, totalis, universalis or any other hair loss disorder except male pattern baldness. Evidence of significant scalp scarring. Has skin cancer or actinic keratoses currently within the balding area. Has a history of skin cancer on the scalp. Has undergone a hair transplant or scalp reduction surgery. Has exhibited hypersensitivity, rash or other abnormal skin reactions, symptoms or lesions to topically applied hair care products in the past year. Has been diagnosed with hypothyroidism or hyperthyroidism within the past year. Has taken or applied any of the following medications known to induce hypotrichosis (abnormal hair loss), and/or hypertrichosis (abnormal hair growth). Medications taken or used in the past 6 months Finasteride -hair growth product (PropeciaÒ or ProscarÒ) Topical or systemic hair growth products (commercial or investigative) e.g. minoxidil (RogaineÒ), NioxinÒ, dutasteride Chemotherapeutic agents Systemic Retinoids (e.g. acitretin, etretinate, isotretinoin, Vitamin A > 5,000 IU (per day) Immunosuppressives (e.g. tacrolimus, cyclosporine A) Antimetabolic agents. (e.g. FludaraÒ, LeustatinÒ Antimitotic agents Anti-androgens (e.g. flutamide, spironolactone, cyproterone acetate) Androgens (e.g. testosterone, methyl testosterone, danazol) DHEA, androstenedione Ketaconazole -systemic (antifungal) Ginseng (herb) Saw Palmetto Diazoxide (hyperglycemic, antihypertensive agent) Anticoagulants (e.g. dicumarol, heparin, warfarin) Interferon Beta blockers (e.g. AcebutololÒ,, AtenololÒ, propranolol, TimololÒ, MetoprololÒ) Antiepileptic and anticonvulsants (e.g. valproic acid, carbamazepine, diphenylhydantoin) Antithyroid drugs (e.g. carbimazole, methimazole, methylthiouracil, propylthiouracil) Topical corticosteroids on scalp or applied to more than 25% of the body surface area Systemic corticosteroids Topical ketaconazole shampoo or cream Has a significant medical condition including, but not limited to: Hypertension (acceptable if controlled by other than a beta blocker); angina, myocardial infarction; history of fainting or dizziness; history of kidney or urinary disorders; diabetes; hemophilia or any condition determined by the Investigator as significant and therefore considered a cause for exclusion Has recently been on, or is currently on a medically managed weight reduction program. Has had a significant febrile illness (high fever lasting several days) within 8 weeks of the Baseline visit. Has participated in an investigational drug study within 4 weeks of the Baseline visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minoxidil<br>Patients received Minoxidil (same strength as sold over the counter) twice a day for 8 weeks. | Other: Minoxidil<br>* Over the counter Rogaine, twice a day for 8 weeks<br>* Other names: Rogaine;|
| Placebo Comparator: Placebo<br>Placebo arm | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of change in gene expression before and after topical minoxidil application |  | at baseline and after 8 weeks of treatment | 
| Differences ing ene expression in two different regions of the scalp, frontal and vertex. |  | Baseline and after 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgenetic Alopecia, Minoxidil, Microarray