Microarray Analysis of Scalp Biopsies After Minoxidil Treatment

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Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Analysis of change in gene expression before and after topical minoxidil application


Condition

Androgenetic Alopecia

Intervention

Minoxidil

Study Arms / Comparison Groups

 Minoxidil
Description:  Patients received Minoxidil (same strength as sold over the counter) twice a day for 8 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

April 2011

Completion Date

April 2012

Primary Completion Date

April 2012

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.
      

Gender

Male

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Pratima Karnik, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01309191

Organization ID

12-10-24

Secondary IDs

338259

Responsible Party

Principal Investigator

Study Sponsor

University Hospitals Cleveland Medical Center

Collaborators

 University of California, San Francisco

Study Sponsor

Pratima Karnik, Ph.D., Principal Investigator, UH Case Medical Center


Verification Date

February 2014