Clinical trial NCT01309191: Microarray Analysis of Scalp Biopsies After Minoxidil Treatment
Official title: Microarray Analysis of Scalp Biopsies in Subjects With Androgenetic Alopecia Before and After the Use of Topical Minoxidil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Keywords: Androgenetic Alopecia
Minoxidil
Microarray
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Kaiser Permanente
First posted: 2011-03-07
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

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.

Primary outcomes:
measure: Analysis of change in gene expression before and after topical minoxidil application
timeFrame: at baseline and after 8 weeks of treatment
measure: Differences ing ene expression in two different regions of the scalp, frontal and vertex.
timeFrame: Baseline and after 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Skin Study Center, UH Case Medical Center
state: Ohio
Study officials:
affiliation: UH Case Medical Center
name: Pratima Karnik, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price VH. Treatment of hair loss. N Engl J Med. 1999 Sep 23;341(13):964-73. doi: 10.1056/NEJM199909233411307. No abstract available.