Microarray Analysis of Scalp Biopsies After Minoxidil Treatment

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Kaiser Permanente
Information provided by (Responsible Party):
Pratima Karnik Ph.D., University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01309191
First received: March 4, 2011
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Androgenetic Alopecia
Drug: Minoxidil
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Microarray Analysis of Scalp Biopsies in Subjects With Androgenetic Alopecia Before and After the Use of Topical Minoxidil

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Analysis of change in gene expression before and after topical minoxidil application [ Time Frame: at baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Differences ing ene expression in two different regions of the scalp, frontal and vertex. [ Time Frame: Baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minoxidil
Patients received Minoxidil (same strength as sold over the counter) twice a day for 8 weeks.
Drug: Minoxidil
Over the counter Rogaine, twice a day for 8 weeks
Other Name: Rogaine
Placebo Comparator: Placebo
Placebo arm
Other: Placebo

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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309191

Locations
United States, Ohio
Skin Study Center, UH Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
University of California, San Francisco
Kaiser Permanente
Investigators
Principal Investigator: Pratima Karnik, Ph.D. UH Case Medical Center
  More Information

Publications:
Responsible Party: Pratima Karnik Ph.D., Assistant Professor, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01309191     History of Changes
Other Study ID Numbers: 12-10-24, 338259
Study First Received: March 4, 2011
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Androgenetic Alopecia
Minoxidil
Microarray

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on April 16, 2014