Microarray Analysis of Scalp Biopsies After Minoxidil Treatment

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.

Inclusion Criteria:

1. Is a male

2. Is in general good health

3. 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

4. Has read, signed and received a copy of the Informed Consent Form prior to initiation
of the study procedures

5. Is willing to follow all instructions and able to participate in the entire study,
returning for all specified visits

6. Between the age of 18 to 49 years old, inclusively

Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Has a history of alopecia areata, totalis, universalis or any other hair loss
disorder except male pattern baldness.

5. Evidence of significant scalp scarring.

6. Has skin cancer or actinic keratoses currently within the balding area.

7. Has a history of skin cancer on the scalp.

8. Has undergone a hair transplant or scalp reduction surgery.

9. Has exhibited hypersensitivity, rash or other abnormal skin reactions, symptoms or
lesions to topically applied hair care products in the past year.

10. Has been diagnosed with hypothyroidism or hyperthyroidism within the past year.

11. 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

12. 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

13. Has recently been on, or is currently on a medically managed weight reduction
program.

14. Has had a significant febrile illness (high fever lasting several days) within 8
weeks of the Baseline visit.

15. Has participated in an investigational drug study within 4 weeks of the Baseline
visit.