HealthyPhase 1NCT06015516
Bioavailability Clinical Trial of Oral Minoxidil 1 mg
A Phase 1 study testing Minoxidil Tablets and Minoxidil topical solution 20 mg/ml in people with Healthy, run by Industrial Farmacéutica Cantabria, S.A. at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn about the pharmacokinetic profile (behaviour of the drug in the body) of a new oral formulation of minoxidil administered in healthy volunteers. The main question that is to answer is to evaluate the bioavailability of the oral test formulation of minoxidil. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Minoxidil Tablets and Minoxidil topical solution 20 mg/ml
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2024to 8 Mar 2024
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women, who after receiving information about the study design, the objectives, the possible risks that could be derived from it and the fact that they can refuse to collaborate at any time, give their written informed consent to participate in the study.
- Aged from 18 to 55 years old.
- No clinically significant organic or psychic conditions.
- No clinically significant abnormalities in medical records and physical examination.
- No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis.
- No clinically significant abnormalities in vital signs and electrocardiogram.
- Women of child-bearing potential age women participating in the study will compromise to use a high effective contraceptive method or will be abstinent during their participation in the study.
Who cannot join
- Subjects affected by an organic or psychic condition. Before a volunteer is included, all the safety parameters defined in points 7.3 will be considered. Those who present clinically significant analytical alterations and in whom biochemical kidney and/or liver damage markers are outside the normal range applied by the laboratory will be excluded [GOT, GPT and/or GGT >2.5*ULN and total bilirrubin >1.5*ULN (total bilirrubin >1.5*ULN is acceptable if the direct bilirrubin is <35%)].
- Subjects who have received prescribed pharmacological treatment in the last 15 days or abstinent of medication in the 48 hours prior to receiving the study medication, but women are allowed taking contraceptives. Contraceptive methods must be used at least 4 weeks prior to entry visit and not to be changed for the duration of the study.
- Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
- History of sensitivity to any drug.
- Positive drug screening for cannabis, opiates, cocaine and amphetamines.
- Smoker.
Show all 13Show fewer
- Daily consumers of alcohol and/or acute alcohol poisoning over the last week.
- Having donated blood in the last month before start of the study.
- Pregnant or breastfeeding women.
- Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
- Inability to follow the instructions or collaborate during the study.
- History of difficulty in swallowing
- Alterations on the scalp such as erythema, dryness or any other condition that at investigator criteria could affect the absortion of the topical solution.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Crossover Bioavailability Clinical Trial of Oral Minoxidil 1 MG, After Single and Multiple Dose Administration to Healthy Volunteers Under Fasting Conditions.
The goal of this clinical trial is to learn about the pharmacokinetic profile (behaviour of the drug in the body) of a new oral formulation of minoxidil administered in healthy volunteers.
The main question that is to answer is to evaluate the bioavailability of the oral test formulation of minoxidil. The secondary onjectives is to compare it with the formulation already on the market (i.e . Regaxidil® 20 mg/mL cutaneous solution).
Read more
It is planned that 14 healthy female volunteers of legal age (without any known pathology) participate in the study. The expected duration of the study is approximately 23-56 days.
Each volunteer that decide to participate in this study will be sequentially administered one of the formulations planned for the study: either the test formulation (oral minoxidil tablets of 1 mg, developed by Industrial Farmacéutica Cantabria, S.A.), or the reference formulation (minoxidil skin solution, 20 mg/mL, marketed by Industrial Farmacéutica Cantabria, S.A.). After five days of administration of one of the study formulations, at least 7 days will elapse before starting an additional five days of administration of the other study formulation that had not been administered in the first sequence. Assignment to this sequence of administration of the study formulations (oral formulation or topical solution) shall be completely randomised.
In each of these sequential periods of five days of administration of the study formulations, the concentration of minoxidil will be quantified in blood samples, which will be taken from each of the volunteers at certain times after the administration of the medication. These blood analyses will enable to determine the parameters that define the pharmacokinetic profile of the new oral formulation under study.
Read the detailed description
This is a phase I, oral multiple-dose, open-label, crossover and randomized clinical trial, 2 sequences, 2 periods, in which subjects will be hospitalized from 10 h before to 12 hours after the first and fifth doses under fasting conditions in both periods.
The study will be blinded only for the plasma concentrations determination of minoxidil.
It is planned to include 14 healthy women volunteers, aged from 18 to 55 years old. The overall duration of the study is estimated at 24-56 days, from recruitment of the volunteers to the last examination.
The test drug is minoxidil 1 mg tablets, manufactured by Industrial Farmacéutica Cantabria, S.A. It will be administered a total of five 1 mg doses (once a day) per oral, under fasting conditions. The reference drug is minoxidil 20 mg/ml (2%) topical solution, marketed in Spain by Industrial Farmacéutica Cantabria, S.A., under the name the trade name of Regaxidil®. It will be applied five 1 mL doses (once a day) topical route, under fasting conditions.
Each one of the subjects will receive a daily dose during five days of minoxidil test or reference in each one of the two periods according to the corresponding randomization sequence, after at least 7 days washout period between each one of admission days.
The main objective is to evaluate the relative bioavailability of the oral test formulation of minoxidil 1 mg after single dose and multiple dose (at steady state). The bioavailability of oral formulation will be evaluated from the AUC0-t and Cmax for single dose on the first administration day and AUC(0-τ)SS, Cmax,ss and Cτ,ss on the steady state of minoxidil. Tmax and Tmax,ss and fluctuation of minoxidil will be also calculated. All the pharmacokinetic parameters will be calculated from the plasma concentrations of minoxidil of the formulation.
- Conditions
- Healthy
- Being tested
- Minoxidil Tablets, Minoxidil topical solution 20 mg/ml
- Keywords
- Bioavailability, Clinical trial, minoxidil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minoxidil TabletsDrug
Since oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil.
Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period.
Minoxidil topical solution 20 mg/mlDrug
Since oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil.
Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Test: Oral minoxidil 1 mg tablets | Experimental | Participants will be administered one tablet of oral minoxidil 1mg once a day, orally, after fasting for at least 10 hours, with 240 mL or 8 Oz. of water, and fasting for a further 5 hours. Receives: Drug: Minoxidil Tablets |
| Treatment Reference: Regaxidil 20 mg/ml (2%) topical solution | Active comparator | Participants will be administered topically on the scalp after fasting for at least 10 hours pre-dose and 5 hours post-dose. After the administration subject should not wash her head for at least 5 hours. Each one mL dose of 2% topical minoxidil will be carefully measured to provide 20 mg of minoxidil using the syringe provided with each bottle. Receives: Drug: Minoxidil topical solution 20 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to the last determination (AUC0-t and AUC(0-τ)ss) for minoxidil.
According to the recommendations of the regulatory authorities, for the analysis of the compared bioavailability of the formulations from single dose and under steady-state conditions, the primary endpoint will be the area under the curve during a dosage interval (AUC0-t and AUC(0-τ)ss) calculated using the linear trapezoidal method, maximum plasma concentration (Cmax and Cmax,ss) and concentration at the end of the dosing interval (Cτ,ss) at steady state calculated from the plasma concentrations of minoxidil.
Measured: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
Maximum observed plasma concentration (Cmax and Cmax,ss) for minoxidil from time zero to the last determination at steady state (Cτ,ss).
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
According to the recommendations of the regulatory authorities, for the analysis of the compared bioavailability of the formulations from single dose and under steady-state conditions, the primary endpoint will be the area under the curve during a dosage interval (AUC0-t and AUC(0-τ)ss) calculated using the linear trapezoidal method, maximum plasma concentration (Cmax and Cmax,ss) and concentration at the end of the dosing interval (Cτ,ss) at steady state calculated from the plasma concentrations of minoxidil.
Measured: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
Secondary outcomes (3)
Area Under the Curve (AUC) for both minoxidil formulations.
The relative bioavailability of the oral test formulation of minoxidil is obtained by analysing the AUC from plasma concentrations of both formulations of minoxidil (oral and topical solution) and then these will compared.
Measured: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
Maximum Plasma Concentration (Cmax) and Peak Cmax steady state for both minoxidil formulations.
The relative bioavailability of the oral test formulation of minoxidil is obtained by analysing the fhe peak concentration (Cmax and Cmax,ss) from plasma concentrations of both formulations of minoxidil (oral and topical solution) and then these will compared.
Measured: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
To evaluate the safety and tolerability of oral minoxidil .
The safety profile of oral minoxidil will be evaluated by analysing the incidence of adverse events of the oral test formulation compared the commercial formulation. The safety parameters will be expressed individually as mean values +/- standard deviation.
Measured: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start9 Feb 2024
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Industrial Farmacéutica Cantabria, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dolores Ochoa Mazarro, Principal investigator, Clinical Trial Unit, Clinical Pharmacology Department Hospital Universitario de La Princesa (Madrid, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015516
- Sponsor's protocol ID
- P23112a
- Other IDs
- 2023-503796-14-00, 2023
- Status last verified
- Mar 2024
- First submitted
- 31 May 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14996087Shamsaldeen OS, Al Mubki T, Shapiro J. Topical agents for hair growth promotion: what is out there? Skin Therapy Lett. 2013 Jun;18(4):5-7.
PubMed 24310642Vano-Galvan S, Pirmez R, Hermosa-Gelbard A, Moreno-Arrones OM, Saceda-Corralo D, Rodrigues-Barata R, Jimenez-Cauhe J, Koh WL, Poa JE, Jerjen R, Trindade de Carvalho L, John JM, Salas-Callo CI, Vincenzi C, Yin L, Lo-Sicco K, Waskiel-Burnat A, Starace M, Zamorano JL, Jaen-Olasolo P, Piraccini BM, Rudnicka L, Shapiro J, Tosti A, Sinclair R, Bhoyrul B. Safety of low-dose oral minoxidil for hair loss: A multicenter study of 1404 patients. J Am Acad Dermatol. 2021 Jun;84(6):1644-1651. doi: 10.1016/j.jaad.2021.02.054. Epub 2021 Feb 24.
PubMed 33639244
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Crossover Bioavailability Clinical Trial of Oral Minoxidil 1 MG, After Single and Multiple Dose Administration to Healthy Volunteers Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT06015516
- Acronym / sponsor ID
- P23112a
- Conditions
- Healthy
- Keywords
- Bioavailability, Clinical trial, minoxidil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Industrial Farmacéutica Cantabria, S.A.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 29 Aug 2023 (actual)
- 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 goal of this clinical trial is to learn about the pharmacokinetic profile (behaviour of the drug in the body) of a new oral formulation of minoxidil administered in healthy volunteers.
The main question that is to answer is to evaluate the bioavailability of the oral test formulation of minoxidil. The secondary onjectives is to compare it with the formulation already on the market (i.e . Regaxidil® 20 mg/mL cutaneous solution).
It is planned that 14 healthy female volunteers of legal age (without any known pathology) participate in the study. The expected duration of the study is approximately 23-56 days.
Each volunteer that decide to participate in this study will be sequentially administered one of the formulations planned for the study: either the test formulation (oral minoxidil tablets of 1 mg, developed by Industrial Farmacéutica Cantabria, S.A.), or the reference formulation (minoxidil skin solution, 20 mg/mL, marketed by Industrial Farmacéutica Cantabria, S.A.). After five days of administration of one of the study formulations, at least 7 days will elapse before starting an additional five days of administration of the other study formulation that had not been administered in the first sequence. Assignment to this sequence of administration of the study formulations (oral formulation or topical solution) shall be completely randomised.
In each of these sequential periods of five days of administration of the study formulations, the concentration of minoxidil will be quantified in blood samples, which will be taken from each of the volunteers at certain times after the administration of the medication. These blood analyses will enable to determine the parameters that define the pharmacokinetic profile of the new oral formulation under study.
Detailed description
This is a phase I, oral multiple-dose, open-label, crossover and randomized clinical trial, 2 sequences, 2 periods, in which subjects will be hospitalized from 10 h before to 12 hours after the first and fifth doses under fasting conditions in both periods.
The study will be blinded only for the plasma concentrations determination of minoxidil.
It is planned to include 14 healthy women volunteers, aged from 18 to 55 years old. The overall duration of the study is estimated at 24-56 days, from recruitment of the volunteers to the last examination.
The test drug is minoxidil 1 mg tablets, manufactured by Industrial Farmacéutica Cantabria, S.A. It will be administered a total of five 1 mg doses (once a day) per oral, under fasting conditions. The reference drug is minoxidil 20 mg/ml (2%) topical solution, marketed in Spain by Industrial Farmacéutica Cantabria, S.A., under the name the trade name of Regaxidil®. It will be applied five 1 mL doses (once a day) topical route, under fasting conditions.
Each one of the subjects will receive a daily dose during five days of minoxidil test or reference in each one of the two periods according to the corresponding randomization sequence, after at least 7 days washout period between each one of admission days.
The main objective is to evaluate the relative bioavailability of the oral test formulation of minoxidil 1 mg after single dose and multiple dose (at steady state). The bioavailability of oral formulation will be evaluated from the AUC0-t and Cmax for single dose on the first administration day and AUC(0-τ)SS, Cmax,ss and Cτ,ss on the steady state of minoxidil. Tmax and Tmax,ss and fluctuation of minoxidil will be also calculated. All the pharmacokinetic parameters will be calculated from the plasma concentrations of minoxidil of the formulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Test: Oral minoxidil 1 mg tablets | Experimental | Drug: Minoxidil TabletsParticipants will be administered one tablet of oral minoxidil 1mg once a day, orally, after fasting for at least 10 hours, with 240 mL or 8 Oz. of water, and fasting for a further 5 hours. |
| Treatment Reference: Regaxidil 20 mg/ml (2%) topical solution | Active comparator | Drug: Minoxidil topical solution 20 mg/mlParticipants will be administered topically on the scalp after fasting for at least 10 hours pre-dose and 5 hours post-dose. After the administration subject should not wash her head for at least 5 hours. Each one mL dose of 2% topical minoxidil will be carefully measured to provide 20 mg of minoxidil using the syringe provided with each bottle. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women, who after receiving information about the study design, the objectives, the possible risks that could be derived from it and the fact that they can refuse to collaborate at any time, give their written informed consent to participate in the study.
- Aged from 18 to 55 years old.
- No clinically significant organic or psychic conditions.
- No clinically significant abnormalities in medical records and physical examination.
- No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis.
Key exclusion criteria (13 listed)
- Subjects affected by an organic or psychic condition. Before a volunteer is included, all the safety parameters defined in points 7.3 will be considered. Those who present clinically significant analytical alterations and in whom biochemical kidney and/or liver damage markers are outside the normal range applied by the laboratory will be excluded [GOT, GPT and/or GGT >2.5*ULN and total bilirrubin >1.5*ULN (total bilirrubin >1.5*ULN is acceptable if the direct bilirrubin is <35%)].
- Subjects who have received prescribed pharmacological treatment in the last 15 days or abstinent of medication in the 48 hours prior to receiving the study medication, but women are allowed taking contraceptives. Contraceptive methods must be used at least 4 weeks prior to entry visit and not to be changed for the duration of the study.
- Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
- History of sensitivity to any drug.
- Positive drug screening for cannabis, opiates, cocaine and amphetamines.
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 |
|---|---|---|
| Minoxidil TabletsSince oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil. Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period. | Drug | Treatment Test: Oral minoxidil 1 mg tablets |
| Minoxidil topical solution 20 mg/mlSince oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil. Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period. | Drug | Treatment Reference: Regaxidil 20 mg/ml (2%) topical solution |
Primary outcome
Area Under the Curve From Time Zero to the last determination (AUC0-t and AUC(0-τ)ss) for minoxidil.
Time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
According to the recommendations of the regulatory authorities, for the analysis of the compared bioavailability of the formulations from single dose and under steady-state conditions, the primary endpoint will be the area under the curve during a dosage interval (AUC0-t and AUC(0-τ)ss) calculated using the linear trapezoidal method, maximum plasma concentration (Cmax and Cmax,ss) and concentration at the end of the dosing interval (Cτ,ss) at steady state calculated from the plasma concentrations of minoxidil.
Maximum observed plasma concentration (Cmax and Cmax,ss) for minoxidil from time zero to the last determination at steady state (Cτ,ss).
Time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. According to the recommendations of the regulatory authorities, for the analysis of the compared bioavailability of the formulations from single dose and under steady-state conditions, the primary endpoint will be the area under the curve during a dosage interval (AUC0-t and AUC(0-τ)ss) calculated using the linear trapezoidal method, maximum plasma concentration (Cmax and Cmax,ss) and concentration at the end of the dosing interval (Cτ,ss) at steady state calculated from the plasma concentrations of minoxidil.
3 secondary outcomes
Area Under the Curve (AUC) for both minoxidil formulations.
Time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
Maximum Plasma Concentration (Cmax) and Peak Cmax steady state for both minoxidil formulations.
Time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
To evaluate the safety and tolerability of oral minoxidil .
Time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
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 21 Aug 2024.
- 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.
- Background: PubMed 24310642Shamsaldeen OS, Al Mubki T, Shapiro J. Topical agents for hair growth promotion: what is out there? Skin Therapy Lett. 2013 Jun;18(4):5-7.
- Background: PubMed 33639244Vano-Galvan S, Pirmez R, Hermosa-Gelbard A, Moreno-Arrones OM, Saceda-Corralo D, Rodrigues-Barata R, Jimenez-Cauhe J, Koh WL, Poa JE, Jerjen R, Trindade de Carvalho L, John JM, Salas-Callo CI, Vincenzi C, Yin L, Lo-Sicco K, Waskiel-Burnat A, Starace M, Zamorano JL, Jaen-Olasolo P, Piraccini BM, Rudnicka L, Shapiro J, Tosti A, Sinclair R, Bhoyrul B. Safety of low-dose oral minoxidil for hair loss: A multicenter study of 1404 patients. J Am Acad Dermatol. 2021 Jun;84(6):1644-1651. doi: 10.1016/j.jaad.2021.02.054. Epub 2021 Feb 24.
- Summary of Product Characteristics (SmPC): Minoxidil 20 mg/ml solución cutáneaLink provided by the sponsor.
- Summary of Product Characteristics (SmPC): Minoxidil 10 mg tablets.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dolores Ochoa Mazarro principal investigator
Clinical Trial Unit, Clinical Pharmacology Department Hospital Universitario de La Princesa (Madrid, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minoxidil Tablets and Minoxidil topical solution 20 mg/ml in people with Healthy, run by Industrial Farmacéutica Cantabria, S.A. at 1 site in Spain.
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 7 inclusion and 13 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 21 Aug 2024. 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 Spain. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Area Under the Curve From Time Zero to the last determination (AUC0-t and AUC(0-τ)ss) for minoxidil. (time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.). 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 NCT06015516, which also lists 3 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 21 Aug 2024.