Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss - Full Text View

Purpose

This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.

Condition	Intervention	Phase
Female Pattern Hair Loss	Drug: Spironolactone Drug: Minoxidil	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy of Therapy With the Anti-androgen Spironolactone Compared to Topical Minoxidil in Female Pattern Hair Loss

Resource links provided by NLM:

Drug Information available for: Spironolactone Minoxidil

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

hair density [ Time Frame: after 3, 6 and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

percentage of subjects who experience side effects [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
subject assessment of treatment effect [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must be premenopausal women older than 18 with female pattern hair loss.

Exclusion Criteria:

Androgen excess
Other scalp or hair disorders
Contraindications to spironolactone treatment, especially pregnancy, electrolyte imbalances, history of breast cancer, or intake of interfering drugs
Contraindications to minoxidil treatment, especially patients who are allergic to this treatment or have a history of low blood pressure or irregular heart beats

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175617

Contacts

Contact: Andreas Finner

604 875 4747

andreas.finner@vch.ca

Locations

Canada, British Columbia
UBC Division of Dermatology, Hair Research and Treatment Centre	Recruiting
Vancouver, British Columbia, Canada, V6G 1Y6
Contact: Andreas Finner 604 875 4747
Principal Investigator: Jerry Shapiro, MD

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Jerry Shapiro, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175617 History of Changes
Other Study ID Numbers:	C05-0060
Study First Received:	September 13, 2005
Last Updated:	November 15, 2011
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Skin Diseases
Pathological Conditions, Anatomical
Androgen Antagonists
Androgens
Minoxidil
Spironolactone
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Aldosterone Antagonists
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on May 21, 2013