Female Pattern Hair LossNCT02486848
Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil
A study testing 5% Topical Minoxidil Solution and 15% Topical Minoxidil Solution in people with Female Pattern Hair Loss and Androgenetic Alopecia, run by Maja Kovacevic, MD at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Female Pattern Hair Loss, Androgenetic Alopecia
- What is being tested?
- 5% Topical Minoxidil Solution and 15% Topical Minoxidil Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to Dec 2016
- Phase
- Interventional
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Female Pattern Hair Loss, Androgenetic Alopecia
- Being tested
- 5% Topical Minoxidil Solution, 15% Topical Minoxidil Solution
- Keywords
- Hairloss, Female Pattern Hair Loss, Androgenetic Alopecia, Minoxidil
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Topical Minoxidil SolutionDrug
5% Topical Minoxidil Solution
15% Topical Minoxidil SolutionDrug
15% Topical Minoxidil Solution
| Study group | Role | What they receive |
|---|---|---|
| 5% Topical Minoxidil Solution | Placebo comparator | 5% Topical Minoxidil Solution Receives: Drug: 5% Topical Minoxidil Solution |
| 15% Topical Minoxidil Solution | Active comparator | 15% Topical Minoxidil Solution Receives: Drug: 15% Topical Minoxidil Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Area Hair Count
Target Area Hair Count. Number of hairs measured in the target area by macrophotography
Measured: baseline to week 24
Subjects Ratings
Subjects Ratings
Measured: baseline to week 24
Secondary outcomes (2)
Target Area Hair Count
Target Area Hair Count. Number of hairs measured in the target area by macrophotography.
Measured: baseline to week 12
Expert Panel Global Photography Assessment
Treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth
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 Jul 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Female Pattern Hair LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maja Kovacevic, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Maja Kovacevic, MD, Applied Biology, Inc.
- Investigators
- Maja Kovacevic, MD, Principal investigator, University of Rome, Italy ("G. Marconi")
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486848
- Sponsor's protocol ID
- FI-DRUG-MINOXIDIL-001
- Status last verified
- Jan 2017
- First submitted
- 25 Jun 2015
- Last updated
- 24 Jan 2017
- 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 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil
- ClinicalTrials.gov ID
- NCT02486848
- Acronym / sponsor ID
- FI-DRUG-MINOXIDIL-001
- Conditions
- Female Pattern Hair Loss, Androgenetic Alopecia
- Keywords
- Hairloss, Female Pattern Hair Loss, Androgenetic Alopecia, Minoxidil
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maja Kovacevic, MDIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Jul 2015 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% Topical Minoxidil Solution | Placebo comparator | Drug: 5% Topical Minoxidil Solution5% Topical Minoxidil Solution |
| 15% Topical Minoxidil Solution | Active comparator | Drug: 15% Topical Minoxidil Solution15% Topical Minoxidil Solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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% Topical Minoxidil Solution5% Topical Minoxidil Solution | Drug | 5% Topical Minoxidil Solution |
| 15% Topical Minoxidil Solution15% Topical Minoxidil Solution | Drug | 15% Topical Minoxidil Solution |
Primary outcome
Target Area Hair Count
Time frame: baseline to week 24
Target Area Hair Count. Number of hairs measured in the target area by macrophotography
Subjects Ratings
Time frame: baseline to week 24
Subjects Ratings
2 secondary outcomes
Target Area Hair Count
Time frame: baseline to week 12
Expert Panel Global Photography Assessment
Time frame: baseline to week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- 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.
Maja Kovacevic, MD principal investigator
University of Rome, Italy ("G. Marconi")
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% Topical Minoxidil Solution and 15% Topical Minoxidil Solution in people with Female Pattern Hair Loss and Androgenetic Alopecia, run by Maja Kovacevic, MD at 1 site in Italy.
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 10 inclusion and 16 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: withdrawn, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
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 NCT02486848, 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 24 Jan 2017.