Androgenic AlopeciaPhase 1NCT05611593
Study to Evaluate Safety & Usability of a New Formulation for Male Androgenetic Alopecia
A Phase 1 study testing FOL100 and Propecia 1Mg Tablet in people with Androgenic Alopecia, run by Follicle Pharma Ltd at 3 sites in Israel.
Trial summary
The CSP-001-FOL1 clinical study is aimed to investigate whether local topical administration of FOL100 lotion will be safe for the patient and will not cause local or systemic skin or other adverse events. It is also aimed at indicating effectiveness as compared with oral Finasteride 1mg. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- FOL100 and Propecia 1Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesIsrael
- Study dates
- 20 Oct 2022to Feb 2025
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent will be signed by the subject before starting any study related procedures.
- Male subject between the ages of 18 to 45 years old.
- Male subject with mild to moderate vertex male-pattern hair loss, classified as grade III vertex to V, according to the modified Norwood/Hamilton Scale.
- Subject must be willing to maintain normal shampooing habits and products during the study.
- Fitzpatrick skin phototype classification of I-IV.
- Subjects will agree to maintain the same haircut and color throughout the study, with no significant changes that will interfere with study objectives, as determined by the investigator.
- Ability to understand and cooperate with the investigator and to comply with the requirements of the study protocol.
Who cannot join
- Clinically significant abnormal skin findings on the scalp, which in the opinion of the investigator, could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders, or any other abnormality.
- Hair transplant surgery or hair weaving.
- Clinically significant and active physical illness that could interfere with study objectives or may risk patient safety as determined by the Investigator during screening.
- Ascertained or presumptive hypersensitivity to the active principle and/or any of the formulation ingredients; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of the investigator may affect subject safety or the outcome of the study.
- History of local infections of the skin or subcutaneous tissues of the head within 3 months prior to study enrollment.
- Clinically significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases, which in the opinion of the investigator may affect subject safety or the outcome of the study.
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- Suspicion of malignancy, including prostate cancer.
- Subject whose sexual partner(s) is pregnant or plan to become pregnant.
- Concurrent use of systemic corticosteroids, topical corticosteroids in the area treated in the study, anabolic steroids, or over the counter "hair restorers".
- Use of any of the following products 1 year for systemic use and 6 months for topical use: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine ,benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents.
- Use of oral finasteride or dutasteride, within 18 months prior to enrollment and 6 months prior to enrollment for any topical medication that is considered to affect hair growth.
- Use of a therapeutic shampoo for hair loss within 1 month prior to enrollment.
- Light or laser treatment of scalp within 3 months prior to enrollment.
- Unwilling to undergo a superficial ink marking on the scalp vertex during V0.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Helena Martinez, MD
- Recruiting
Sheba Medical Center
Ramat Gan
Anna Lyakhovitsky, MD
- Recruiting
Sourasky Medical Center
Tel Aviv
Amir Koren
About this study
Official title: A Phase-I, Open Label, Multi-Centre Clinical Study to Assess the Safety, Tolerability and Usability of FOL100 Lotion in Comparison to Oral Finasteride, for the Treatment of Androgenetic Alopecia
The CSP-001-FOL1 clinical study is aimed to investigate whether local topical administration of FOL100 lotion will be safe for the patient and will not cause local or systemic skin or other adverse events. It is also aimed at indicating effectiveness as compared with oral Finasteride 1mg. In this non-blinded study, each patient will choose his preferred arm (oral finasteride or FOL100 location). During the study, safety and efficacy will be measured as well as usability.
Read the detailed description
The proposed clinical study aims to test the safety, tolerability and usability of FOL100 compared to the commercially available Finasteride 1mg Propecia in male subjects suffering from AA.
Study endpoints:
Primary Endpoint:
Safety-AE(s) \& SAE(s) incidence rate. Secondary Endpoint: Tolerability \& usability collecting information on safety, tolerability \& usability.
Exploratory Endpoint: Efficacy
- Mean change in total, vellus and non-vellus hair count, total hair density, cumulative hair diameter and mean hair thickness in the target region.
- Global photographic assessments.
- Subject self-assessment.
- Conditions
- Androgenic Alopecia
- Being tested
- FOL100, Propecia 1Mg Tablet
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOL100Drug
FOL100 lotion
Propecia 1Mg TabletDrug
Also called Oral Finasteride
Oral Finasteride
| Study group | Role | What they receive |
|---|---|---|
| FOL100 | Experimental | Subjects will apply FOL100 lotion topically in the defined treatment area. Receives: Drug: FOL100 |
| Propecia 1mg (oral Finasteride) | Active comparator | Participants will receive1 tablet of Propecia 1mg (oral Finasteride) once daily (q.d) Receives: Drug: Propecia 1Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of product application
Adverse event reporting (local and general)
Measured: 28 weeks
Secondary outcomes (1)
Tolerability & Usability
Subject self-assessment by questionnaire
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start20 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Group Assignment
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Follicle Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Solli Brawer, Study director, Follicle Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611593
- Sponsor's protocol ID
- CSP-001-FOL1
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-I, Open Label, Multi-Centre Clinical Study to Assess the Safety, Tolerability and Usability of FOL100 Lotion in Comparison to Oral Finasteride, for the Treatment of Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT05611593
- Acronym / sponsor ID
- CSP-001-FOL1
- Conditions
- Androgenic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Follicle Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 10 Nov 2022 (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 CSP-001-FOL1 clinical study is aimed to investigate whether local topical administration of FOL100 lotion will be safe for the patient and will not cause local or systemic skin or other adverse events. It is also aimed at indicating effectiveness as compared with oral Finasteride 1mg. In this non-blinded study, each patient will choose his preferred arm (oral finasteride or FOL100 location). During the study, safety and efficacy will be measured as well as usability.
Detailed description
The proposed clinical study aims to test the safety, tolerability and usability of FOL100 compared to the commercially available Finasteride 1mg Propecia in male subjects suffering from AA.
Study endpoints:
Primary Endpoint:
Safety-AE(s) \& SAE(s) incidence rate. Secondary Endpoint: Tolerability \& usability collecting information on safety, tolerability \& usability.
Exploratory Endpoint: Efficacy
- Mean change in total, vellus and non-vellus hair count, total hair density, cumulative hair diameter and mean hair thickness in the target region.
- Global photographic assessments.
- Subject self-assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Group Assignment
| Arm | Type | Receives |
|---|---|---|
| FOL100 | Experimental | Drug: FOL100Subjects will apply FOL100 lotion topically in the defined treatment area. |
| Propecia 1mg (oral Finasteride) | Active comparator | Drug: Propecia 1Mg TabletParticipants will receive1 tablet of Propecia 1mg (oral Finasteride) once daily (q.d) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent will be signed by the subject before starting any study related procedures.
- Male subject between the ages of 18 to 45 years old.
- Male subject with mild to moderate vertex male-pattern hair loss, classified as grade III vertex to V, according to the modified Norwood/Hamilton Scale.
- Subject must be willing to maintain normal shampooing habits and products during the study.
- Fitzpatrick skin phototype classification of I-IV.
Key exclusion criteria (14 listed)
- Clinically significant abnormal skin findings on the scalp, which in the opinion of the investigator, could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders, or any other abnormality.
- Hair transplant surgery or hair weaving.
- Clinically significant and active physical illness that could interfere with study objectives or may risk patient safety as determined by the Investigator during screening.
- Ascertained or presumptive hypersensitivity to the active principle and/or any of the formulation ingredients; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of the investigator may affect subject safety or the outcome of the study.
- History of local infections of the skin or subcutaneous tissues of the head within 3 months prior to study enrollment.
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 |
|---|---|---|
| FOL100FOL100 lotion | Drug | FOL100 |
| Propecia 1Mg TabletAlso: Oral FinasterideOral Finasteride | Drug | Propecia 1mg (oral Finasteride) |
Primary outcome
Safety of product application
Time frame: 28 weeks
Adverse event reporting (local and general)
1 secondary outcome
Tolerability & Usability
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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.
Solli Brawer study director
Follicle Pharma Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FOL100 and Propecia 1Mg Tablet in people with Androgenic Alopecia, run by Follicle Pharma Ltd at 3 sites 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 7 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Solli Brawer (+972747366444, info@folliclepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of product application (time frame: 28 weeks). 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 7 Mar 2024.