Minoxidil Response Testing in Females With Female Pattern Hair Loss

NCT02206802 | Completed

• 1 other identifier: AB-IVD-MINOXIDIL-004
• Study Type: observational
• Target: 300
• Locations: 4 countries
• Sites: 5

Brief Summary

The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.

Conditions

Alopecia; Female Pattern Hair Loss

Keywords

Alopecia; Androgenetic Alopecia; Female Pattern Hair Loss; Hair Loss; Minoxidil; Hair Thinning

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count

  Number of hairs measured in the target area by macrophotography.

  baseline to week 24

• Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings

  baseline to week 24

Secondary Outcomes (4)

• Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count

  baseline to week 12

• Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth

  baseline to week 24

• Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region

  baseline to week 24

• Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit

  baseline to week 24

Study Arms (2)

Predicted as non-responders

Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group.

Drug: 5% minoxidil topical foam

Predicted as responders

Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.

Drug: 5% minoxidil topical foam

Interventions

5% minoxidil topical foam DRUG

5% minoxidil topical foam

Also known as: Rogaine 5% minoxidil foam, Regaine 5% minoxidil foam

Predicted as non-responders; Predicted as responders

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females with Female Pattern Hair Loss - Androgenetic Alopecia

You may qualify if:

• Females in overall good health
• Age: 18 or older
• Female pattern hair loss
• 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
• 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
• 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 6 months

Sponsors & Collaborators

• Applied Biology, Inc.: lead

Study Sites (5)

Physicians Hair Institute

Tucson, Arizona, 85719, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Sinclair Dermatology

East Melbourne, 3002, Australia

Location

LTM Medical College & Hospital

Mumbai, 400022, India

Location

Istituto Medico Tricologico/Studi Life Cronos

Florence, 50127, 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plucked hair follicles with visible bulbs

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Sharon Keene, MD

  Physicians Hair Institute

  PRINCIPAL INVESTIGATOR

• Flavio Grasso, MD

  Istituto Medico Tricologico/Studi Life Cronos

  PRINCIPAL INVESTIGATOR

• Rodney Sinclair, MD

  Sinclair Dermatology

  PRINCIPAL INVESTIGATOR

• Rachita Dhurat, MD

  LTM Medical College & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

AU (1); US (2); IN (1); IT (1)