NCT01309191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

March 4, 2011

Last Update Submit

April 28, 2022

Conditions

Androgenetic Alopecia

Keywords

Androgenetic AlopeciaMinoxidilMicroarray

Outcome Measures

Primary Outcomes (2)

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

    at baseline and after 8 weeks of treatment

  • Differences ing ene expression in two different regions of the scalp, frontal and vertex.

    Baseline and after 8 weeks of treatment

Study Arms (2)

Minoxidil

EXPERIMENTAL

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

Other: Minoxidil

Placebo

PLACEBO COMPARATOR

Placebo arm

Other: Placebo

Interventions

MinoxidilOTHER

Over the counter Rogaine, twice a day for 8 weeks

Also known as: Rogaine
Minoxidil
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skin Study Center, UH Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Price VH. Treatment of hair loss. N Engl J Med. 1999 Sep 23;341(13):964-73. doi: 10.1056/NEJM199909233411307. No abstract available.

    PMID: 10498493BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Pratima Karnik, Ph.D.

    UH Case Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 7, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

US(1)