Microarray Analysis of Scalp Biopsies After Minoxidil Treatment

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Kaiser Permanente; University of California, San Francisco
• Treatments: Minoxidil

Criteria

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.