Microarray Analysis of Scalp Biopsies After Minoxidil Treatment

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · Mar 4, 2011

Keywords

ClinConnect Summary

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 ...

Gender

MALE

Eligibility 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.