AlopeciaNCT02206802
Minoxidil Response Testing in Females With Female Pattern Hair Loss
An observational study of Alopecia and Female Pattern Hair Loss, run by Applied Biology, Inc. at 5 sites in 4 countries.
Trial summary
The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alopecia, Female Pattern Hair Loss
- What is being tested?
- 5% minoxidil topical foam
- How many people
- 300 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Jul 2014to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females with Female Pattern Hair Loss - Androgenetic Alopecia
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Physicians Hair Institute
Tucson, Arizona, 85719
About this study
The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.
Read the 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.
- Conditions
- Alopecia, Female Pattern Hair Loss
- Being tested
- 5% minoxidil topical foam
- Keywords
- Alopecia, Androgenetic Alopecia, Female Pattern Hair Loss, Hair Loss, Minoxidil, Hair Thinning
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% minoxidil topical foamDrug
Also called Rogaine 5% minoxidil foam, Regaine 5% minoxidil foam
5% minoxidil topical foam
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 5% minoxidil topical foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to week 24
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
Measured: 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
Number of hairs measured in the target area by macrophotography.
Measured: 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
Measured: 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
Measured: baseline to week 24
Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit
Measured: baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Keene, MD, Principal investigator, Physicians Hair InstituteFlavio Grasso, MD, Principal investigator, Istituto Medico Tricologico/Studi Life CronosRodney Sinclair, MD, Principal investigator, Sinclair DermatologyRachita Dhurat, MD, Principal investigator, LTM Medical College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206802
- Sponsor's protocol ID
- AB-IVD-MINOXIDIL-004
- Status last verified
- Oct 2018
- First submitted
- 31 Jul 2014
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24773771Goren 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.
PubMed 24283387Buhl 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.
PubMed 2230218Messenger 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.
PubMed 14996087
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minoxidil Response Testing in Females With Female Pattern Hair Loss
- ClinicalTrials.gov ID
- NCT02206802
- Acronym / sponsor ID
- AB-IVD-MINOXIDIL-004
- Conditions
- Alopecia, Female Pattern Hair Loss
- Keywords
- Alopecia, Androgenetic Alopecia, Female Pattern Hair Loss, Hair Loss, Minoxidil, Hair Thinning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predicted as non-responders | – | Drug: 5% minoxidil topical foamPatients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group. |
| Predicted as responders | – | Drug: 5% minoxidil topical foamPatients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females with Female Pattern Hair Loss - Androgenetic Alopecia
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- Previous adverse event from topical minoxidil treatment
- History of hypotension
- Uncontrolled hypertension
- Pregnant, nursing, or planning a pregnancy during the study
- Prior hair transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% minoxidil topical foamAlso: Rogaine 5% minoxidil foam, Regaine 5% minoxidil foam5% minoxidil topical foam | Drug | Predicted as non-responders, Predicted as responders |
Primary outcome
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.
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
Time frame: baseline to week 24
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Background: PubMed 24773771Roberts 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.
- Background: PubMed 24283387Goren 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.
- Background: PubMed 2230218Buhl 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.
- Background: PubMed 14996087Messenger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Keene, MD principal investigator
Physicians Hair Institute
Flavio Grasso, MD principal investigator
Istituto Medico Tricologico/Studi Life Cronos
Rodney Sinclair, MD principal investigator
Sinclair Dermatology
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia and Female Pattern Hair Loss, run by Applied Biology, Inc. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, India, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02206802, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.