AcnePhase 1NCT02250859
A Pharmacokinetic Study of Minocycline in Male and Female Volunteers
A Phase 1 study testing FMX101, Minocycline 4% foam in people with Acne, run by Vyne Therapeutics Inc. at 1 site in Israel.
Trial summary
The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101 4% foam product in male and female some of which are with acne Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- FMX101, Minocycline 4% foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Jan 2015
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between 18 and 35 years (inclusive) of age.
- Clear skin or facial acne of any severity, currently untreated
- Otherwise healthy subjects
- Subjects who provide written informed consent to participate in the study.
- Women of childbearing potential who are willing to use 2 reliable methods of contraception or practice abstinence during the study period or be surgically sterilized and agree to undergo repeated pregnancy tests.
- Body Mass Index (BMI) 19.0 to <30.0 kg/m2 and weight ranging between 60-90 kg (males) and 50-85 (females).
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- Non-smoking and no use of any tobacco or nicotine products (by declaration) for a period of at least 6 months prior to screening visit
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs, ECG and a physical examination.
- Shaven facial hair (males)
- Negative HIV, Hepatitis B and Hepatitis C serology tests at screening.
- No clinically significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at screening.
- No known history of alcohol or drug abuse. Negative urinary screen for drugs of abuse determined within 21 days of the start of the study (screening visit).
- Willingness to minimize exposure to sun for 20 days after first dosing
- Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study
Who cannot join
- Documented history or ongoing symptoms of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- Known or suspected pregnancy or lactation or planned pregnancy during the study duration (females)
- Use of topical antibiotics or topical corticosteroids for acne treatment within the past 2 weeks.
- Use of systemic corticosteroids within the past 4 weeks.
- Use of systemic retinoids (e.g. isotretinoin) within the past 6 months.
- Concurrent use of medications known to be photosensitizers because of the possibility of augmented photosensitivity.
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- History or evidence of skin conditions other than acne (eg, eczema) that would interfere with the subject's participation in the study.
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
- Dermatological conditions which might have an effect upon dermal application, e.g.: Psoriasis, mycosis fungoides, widespread acne, facial or back dermatophytosis, severe hyperhydrosis, chronic or recurrent skin infections, ichtyosis
- Excessive hair in the intended application areas
- Current or recent (within 1year) drug or alcohol abuse.
- Known contraindication, hypersensitivity and/or allergy to the study drug or its excipients.
- Subjects with significant allergic response to other drugs
- Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug administration, which is considered of significance by the Principal Investigator.
- Participation in another clinical trial with drugs received within 3 months prior to dosing (calculated from the previous study's last dosing date).
- Subjects who donated blood in the three months or received blood or plasma derivatives in the six months preceding study drug administration.
- Subjects unable to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).
- Subjects who are non-cooperative or unwilling to sign consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multiple Dose Study to Assess the Pharmacokinetic Profile of Minocycline From FMX-101 Foam (4%) in Male and Female Volunteers
The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101 4% foam product in male and female some of which are with acne
Read the detailed description
This is an open-label, single-center, non-randomized, multiple-administrations study in males and females, some of which are with acne.
Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline (4%) foam for sixteen consecutive days.
Each subject will undergo screening procedures within 21 days prior to dosing, to assess his eligibility to participate in the study, including a dermatological assessment of the acne severity and distribution (for subjects with acne).
On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety Follow-up visit will take place on 7-10 days after last dose, which will also include a dermatological assessment of response to treatment
- Conditions
- Acne
- Being tested
- FMX101, Minocycline 4% foam
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMX101, Minocycline 4% foamDrug
Also called FMX101 antibiotic foam
FMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| FMX101 Minocycline 4% foam | Experimental | FMX101, 4% applied to the face, upper chest, upper back and shoulders for sixsteen consecutive days in subjects either with acne or with normal skin Receives: Drug: FMX101, Minocycline 4% foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
AEs will be assessed starting from informed consent signature until end of study)
Measured: 22-25 days
irritation and local reaction
The application area will be examined for irritation and local reaction
Measured: 16 days
Change from baseline in vital signs
sitting BP, HR, RR, oral temperature
Measured: 22-25 days
Cmax
will be assessed after 1 and 16 days of dosing
Measured: 16 days
Tmax
will be assessed after 1 and 16 days of dosing
Measured: 16 days
AUCT
will be assessed after 1 and 16 days of dosing
Measured: 16 days
T½
will be assessed after 1 and 16 days of dosing
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Atsmon, MD, Principal investigator, Sourasky Medical center, Tel-aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250859
- Sponsor's protocol ID
- FMX101-1
- Status last verified
- Feb 2021
- First submitted
- 21 Sep 2014
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple Dose Study to Assess the Pharmacokinetic Profile of Minocycline From FMX-101 Foam (4%) in Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02250859
- Acronym / sponsor ID
- FMX101-1
- Conditions
- Acne
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Sep 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 purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101 4% foam product in male and female some of which are with acne
Detailed description
This is an open-label, single-center, non-randomized, multiple-administrations study in males and females, some of which are with acne.
Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline (4%) foam for sixteen consecutive days.
Each subject will undergo screening procedures within 21 days prior to dosing, to assess his eligibility to participate in the study, including a dermatological assessment of the acne severity and distribution (for subjects with acne).
On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety Follow-up visit will take place on 7-10 days after last dose, which will also include a dermatological assessment of response to treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMX101 Minocycline 4% foam | Experimental | Drug: FMX101, Minocycline 4% foamFMX101, 4% applied to the face, upper chest, upper back and shoulders for sixsteen consecutive days in subjects either with acne or with normal skin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Men and women between 18 and 35 years (inclusive) of age.
- Clear skin or facial acne of any severity, currently untreated
- Otherwise healthy subjects
- Subjects who provide written informed consent to participate in the study.
- Women of childbearing potential who are willing to use 2 reliable methods of contraception or practice abstinence during the study period or be surgically sterilized and agree to undergo repeated pregnancy tests.
Key exclusion criteria (18 listed)
- Documented history or ongoing symptoms of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- Known or suspected pregnancy or lactation or planned pregnancy during the study duration (females)
- Use of topical antibiotics or topical corticosteroids for acne treatment within the past 2 weeks.
- Use of systemic corticosteroids within the past 4 weeks.
- Use of systemic retinoids (e.g. isotretinoin) within the past 6 months.
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 |
|---|---|---|
| FMX101, Minocycline 4% foamAlso: FMX101 antibiotic foamFMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days | Drug | FMX101 Minocycline 4% foam |
Primary outcome
adverse events
Time frame: 22-25 days
AEs will be assessed starting from informed consent signature until end of study)
irritation and local reaction
Time frame: 16 days
The application area will be examined for irritation and local reaction
Change from baseline in vital signs
Time frame: 22-25 days
sitting BP, HR, RR, oral temperature
Cmax
Time frame: 16 days
will be assessed after 1 and 16 days of dosing
Tmax
Time frame: 16 days
will be assessed after 1 and 16 days of dosing
AUCT
Time frame: 16 days
will be assessed after 1 and 16 days of dosing
T½
Time frame: 16 days
will be assessed after 1 and 16 days of dosing
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 25 Feb 2021.
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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.
Jacob Atsmon, MD principal investigator
Sourasky Medical center, Tel-aviv, Israel
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 FMX101, Minocycline 4% foam in people with Acne, run by Vyne Therapeutics Inc. at 1 site in Israel.
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 14 inclusion and 18 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 25 Feb 2021. 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 Israel. 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?
adverse events (time frame: 22-25 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2021.