Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil

NCT02486848 | Withdrawn

• 1 other identifier: FI-DRUG-MINOXIDIL-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair. The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

Conditions

Female Pattern Hair Loss; Androgenetic Alopecia

Keywords

Hairloss; Female Pattern Hair Loss; Androgenetic Alopecia; Minoxidil

Outcome Measures

Primary Outcomes (2)

• Target Area Hair Count

  Target Area Hair Count. Number of hairs measured in the target area by macrophotography

  baseline to week 24

• Subjects Ratings

  Subjects Ratings

  baseline to week 24

Secondary Outcomes (2)

• Target Area Hair Count

  baseline to week 12

• Expert Panel Global Photography Assessment

  baseline to week 24

Study Arms (2)

5% Topical Minoxidil Solution

PLACEBO COMPARATOR

5% Topical Minoxidil Solution

Drug: 5% Topical Minoxidil Solution

15% Topical Minoxidil Solution

ACTIVE COMPARATOR

15% Topical Minoxidil Solution

Drug: 15% Topical Minoxidil Solution

Interventions

5% Topical Minoxidil Solution DRUG

5% Topical Minoxidil Solution

5% Topical Minoxidil Solution

15% Topical Minoxidil Solution DRUG

15% Topical Minoxidil Solution

15% Topical Minoxidil Solution

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females in overall good health
• Age: 18 to 55
• Female pattern hair loss (Sinclair 2-4)
• Willing to have a mini dot tattoo placed in the target area of the scalp
• Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
• Able to give informed consent
• Non-responder to 5% minoxidil as determined by the MX-IVD test i.e., low minoxidil metabolizer
• Able to comply with the study requirements for 24 consecutive weeks
• Willing to use an adequate method of birth control (if applicable)
• Negative urine pregnancy test

You may not qualify if:

• Previous adverse event from topical minoxidil treatment
• History of hypotension
• Uncontrolled hypertension
• Use of any hypertensive drugs
• Pregnant, nursing, or planning a pregnancy during the study
• Prior hair transplant
• Uses wigs or hair weaves
• Have used minoxidil (topical or oral) anytime during the past 6 months
• Chronic scalp disorders that require medications
• Uses medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
• Folliculitis
• Scalp psoriasis
• Seborrheic dermatitis
• Inflammatory scalp conditions such as lichen planopilaris
• Enrolled in any other medical study or has been enrolled in any medical study in the past 30 days

Sponsors & Collaborators

• Maja Kovacevic, MD: lead

Study Sites (1)

Istituto Scienze Dermatologiche

Florence, Tuscany, Italy

Location

Related Publications (4)

• Roberts J, Desai N, McCoy J, Goren A. Sulfotransferase activity in plucked hair follicles predicts response to topical minoxidil in the treatment of female androgenetic alopecia. Dermatol Ther. 2014 Jul-Aug;27(4):252-4. doi: 10.1111/dth.12130. Epub 2014 Apr 28.

  PMID: 24773771 BACKGROUND

• Goren A, Castano JA, McCoy J, Bermudez F, Lotti T. Novel enzymatic assay predicts minoxidil response in the treatment of androgenetic alopecia. Dermatol Ther. 2014 May-Jun;27(3):171-3. doi: 10.1111/dth.12111. Epub 2013 Nov 27.

  PMID: 24283387 BACKGROUND

• Buhl AE, Waldon DJ, Baker CA, Johnson GA. Minoxidil sulfate is the active metabolite that stimulates hair follicles. J Invest Dermatol. 1990 Nov;95(5):553-7. doi: 10.1111/1523-1747.ep12504905.

  PMID: 2230218 BACKGROUND

• Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. doi: 10.1111/j.1365-2133.2004.05785.x.

  PMID: 14996087 BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Maja Kovacevic, MD

  University of Rome, Italy ("G. Marconi")

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 1, 2015
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

IT (1)