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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02486848
• Other study ID #: FI-DRUG-MINOXIDIL-001
• Status: Withdrawn
• Phase: N/A
• First received: June 25, 2015
• Last updated: January 23, 2017
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Applied Biology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Approximately, 40% of women suffer from female pattern hair loss by the age of 55. Currently, there is only one drug approved by the US FDA for the treatment of female pattern hair loss (AGA) - topical minoxidil.

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female AGA. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. The investigators have developed an in-vitro diagnostic test that correctly identifies, prior to initiating therapy, 95.9% of non-responders to 5% topical minoxidil. The diagnostic test analyzes the sulfotransferase enzymatic activity in hair follicles to determine if a sufficient amount of minoxidil will be converted to the active form required to induce hair growth. Subjects with low enzymatic activity experience little or no therapeutic benefit and a reduced frequency of adverse events.

Consequently, the investigators hypothesize that in subjects with low enzymatic activity (i.e., low minoxidil metabolizers) an increased minoxidil dosage will elicit a therapeutic response with little or no increase in the frequency of adverse events. It is thus the primary purpose of this study 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Responder to 5% minoxidil as determined by the MX-IVD test

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia
• Female Pattern Hair Loss

Intervention

Drug:
• 5% Topical Minoxidil Solution
5% Topical Minoxidil Solution
• 15% Topical Minoxidil Solution
15% Topical Minoxidil Solution

Locations

Country	Name	City	State
Italy	Istituto Scienze Dermatologiche	Florence	Tuscany

Sponsors (1)

Lead Sponsor	Collaborator
Maja Kovacevic, MD

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Area Hair Count	Target Area Hair Count. Number of hairs measured in the target area by macrophotography	baseline to week 24
Primary	Subjects Ratings	Subjects Ratings	baseline to week 24
Secondary	Target Area Hair Count	Target Area Hair Count. Number of hairs measured in the target area by macrophotography.	baseline to week 12
Secondary	Expert Panel Global Photography Assessment	Treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth	baseline to week 24