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Minoxidil Response Testing in Females With Female Pattern Hair Loss

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ClinicalTrials.gov Identifier: NCT02206802
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

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

Condition or disease Intervention/treatment
Alopecia Female Pattern Hair Loss Drug: 5% minoxidil topical foam

Detailed Description:

Topical minoxidil is the only US FDA approved drug used for the treatment of AGA in females. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used once daily for a period of at least 24 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous.

Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker.

Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Minoxidil Response Testing in Females With Female Pattern Hair Loss
Study Start Date : July 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Group/Cohort Intervention/treatment
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
5% minoxidil topical foam
Other Names:
  • Rogaine 5% minoxidil foam
  • Regaine 5% minoxidil 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
5% minoxidil topical foam
Other Names:
  • Rogaine 5% minoxidil foam
  • Regaine 5% minoxidil foam




Primary Outcome Measures :
  1. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count [ Time Frame: baseline to week 24 ]
    Number of hairs measured in the target area by macrophotography.

  2. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings [ Time Frame: baseline to week 24 ]

Secondary Outcome Measures :
  1. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count [ Time Frame: baseline to week 12 ]
    Number of hairs measured in the target area by macrophotography.

  2. 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 [ Time Frame: baseline to week 24 ]
  3. 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 [ Time Frame: baseline to week 24 ]
  4. Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit [ Time Frame: baseline to week 24 ]

Biospecimen Retention:   Samples Without DNA
Plucked hair follicles with visible bulbs


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females with Female Pattern Hair Loss - Androgenetic Alopecia
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206802


Locations
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United States, Arizona
Physicians Hair Institute
Tucson, Arizona, United States, 85719
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Australia
Sinclair Dermatology
East Melbourne, Australia, 3002
India
LTM Medical College & Hospital
Mumbai, India, 400022
Italy
Istituto Medico Tricologico/Studi Life Cronos
Florence, Italy, 50127
Sponsors and Collaborators
Applied Biology, Inc.
Investigators
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Principal Investigator: 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

Publications:
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Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT02206802     History of Changes
Other Study ID Numbers: AB-IVD-MINOXIDIL-004
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Keywords provided by Applied Biology, Inc.:
Alopecia
Androgenetic Alopecia
Female Pattern Hair Loss
Hair Loss
Minoxidil
Hair Thinning

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents