- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01309191
Microarray Analysis of Scalp Biopsies After Minoxidil Treatment
Microarray Analysis of Scalp Biopsies in Subjects With Androgenetic Alopecia Before and After the Use of Topical Minoxidil
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Skin Study Center, UH Case Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Is a male
- Is in general good health
- 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
- Has read, signed and received a copy of the Informed Consent Form prior to initiation of the study procedures
- Is willing to follow all instructions and able to participate in the entire study, returning for all specified visits
- Between the age of 18 to 49 years old, inclusively
Exclusion Criteria:
- 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.
- 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.
- 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.
- Has a history of alopecia areata, totalis, universalis or any other hair loss disorder except male pattern baldness.
- Evidence of significant scalp scarring.
- Has skin cancer or actinic keratoses currently within the balding area.
- Has a history of skin cancer on the scalp.
- Has undergone a hair transplant or scalp reduction surgery.
- Has exhibited hypersensitivity, rash or other abnormal skin reactions, symptoms or lesions to topically applied hair care products in the past year.
- Has been diagnosed with hypothyroidism or hyperthyroidism within the past year.
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
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
- Has recently been on, or is currently on a medically managed weight reduction program.
- Has had a significant febrile illness (high fever lasting several days) within 8 weeks of the Baseline visit.
- Has participated in an investigational drug study within 4 weeks of the Baseline visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Minoxidil
Patients received Minoxidil (same strength as sold over the counter) twice a day for 8 weeks.
|
Over the counter Rogaine, twice a day for 8 weeks
Other Names:
|
Placebo Comparator: Placebo
Placebo arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of change in gene expression before and after topical minoxidil application
Time Frame: at baseline and after 8 weeks of treatment
|
at baseline and after 8 weeks of treatment
|
Differences ing ene expression in two different regions of the scalp, frontal and vertex.
Time Frame: Baseline and after 8 weeks of treatment
|
Baseline and after 8 weeks of treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pratima Karnik, Ph.D., UH Case Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-10-24
- 338259 (Other Grant/Funding Number: Johnson & Johnson)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Androgenetic Alopecia
-
University of FloridaWithdrawnFemale Androgenetic AlopeciaUnited States
-
Suzhou Kintor Pharmaceutical Inc,Completed
-
King Edward Medical UniversityCompletedCombination of SVF and PRP for Androgenetic AlopeciaPakistan
-
Second Affiliated Hospital, School of Medicine,...Recruiting
-
Hope Medicine (Nanjing) Co., LtdRecruitingAndrogenetic AlopeciaChina
-
Indonesia UniversityRecruiting
-
Cassiopea SpAICON Clinical Research; Canfield Scientific Inc.; Ergomed PLC; Pharmapace IncRecruitingAlopecia, AndrogeneticGermany, United States, Poland
-
University of ArizonaTransdermal Cap, Inc.Not yet recruitingAndrogenetic Alopecia
-
Gregory L Smith, MD, MPHRecruitingAndrogenetic AlopeciaUnited States
-
Indonesia UniversityCompletedAndrogenetic AlopeciaIndonesia
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States