Androgenetic AlopeciaPhase 2NCT04774874
A Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers
A Phase 2 study testing Topical formulation in people with Androgenetic Alopecia, run by Follicum AB at 1 site in Germany.
Trial summary
This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16 weeks in healthy male subjects with androgenetic… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Topical formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jun 2020to 29 Jan 2021
- Phase
- Phase 2
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, aged 18-55 years
- Skin phototype II, III and IV according to Fitzpatrick's classification (Fitzpatrick et al. 1974)
- Androgenetic alopecia (AGA) classified according to Hamilton Norwood grade 3V, 4, 5, 5A, 5V (Hamilton, 1951)
- Willing and able to comply with scheduled visits
- Willing to maintain the same hair hygiene products and general hair care habits during the trial period
- Willing to maintain the same hair length and hair color during the trial period
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- Willing to have treatment areas shaved for TrichoLAB® measurement and marked with small semi-permanent dot tattoos
- Willing to avoid prolonged UV exposition and UV tanning beds
- Signed written informed consent before participation in the trial.
- Subjects with a hair length of above 1 cm
Who cannot join
- Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test sites risking to interfere with investigational evaluations
- Any dermatological disorders of the scalp which might interfere with the application of the investigational product (IP) or examination method, such as fungal or bacterial infections, seborrheic dermatitis (except mild forms which are managed with OTC shampoos and which do not require dermatological treatment), psoriasis, eczema, folliculitis, that require chronic use of medication or scalp atrophy
- Any skin pathology (e.g. scar, nevus) or general condition (e.g. uncontrolled thyroid diseases) that in the Investigator's opinion can interfere with the evaluation of the test areas or requires prohibited topical or systemic therapy
- History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
- Diabetes mellitus
- Presence of any acute (e.g. acute infections) or chronic illness (e.g. psoriasis, atopic dermatitis, porphyria, folliculitis) or presence or history of known skin cancer that in the opinion of the Investigators might confound the results of the trial
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- History or clinical signs of keloids or hypertrophic scars
- Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
- Current or within the last 6 months history of severe dietary or weight changes
- Hair transplantation at any time
- Known sensitization to cosmetic hair dyes or hypersensitivity to any ingredients of the IP or tattoo ink.
- Application of topical minoxidil preparation or any other topical over-the counter (OTC) or prescription medication for hair re-growth to scalp for 4 weeks or more during a 6 months period before enrollment.
- Use of or planned use of shampoo with expected medicinal effect on the scalp (e.g. but not limited to anti-dandruff containing ketoconazole, anti-psoriatic, anti-fungal or shampoo containing urea, caffeine, acetylsalicylic acid, etc.) during the course of trial
- Topical treatments of the scalp including corticosteroids, tacrolimus, retinoids or other treatments that may affect hair growth in the last 3 months as well as during the trial.
- Platelet rich plasma (PRP) or any mesotherapy treatment on scalp during the last 12 months as well as during the trial.
- Systemic therapy using retinoids, cyclosporine, beta blockers or corticosteroids within the last 6 months as well as during the trial.
- Scalp procedures e.g. surgery, laser, light, micro-needling within the last 6 months as well as during the trial.
- Finasterid (e.g. Propecia®) or Dutasteride intake or topical application in the last 12 months, or any systemic hair therapy medication in the last 12 months as well as during the trial.
- Other systemic therapy which in the opinion of the Investigator might affect hair growth
- Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifyllin, nitroglycerine) or anticoagulating drugs (e.g. heparine, cumarines, new oral anticoagulants, regular intake of acetylsalicylic acid)
- Current or within 3 months prior to first dosing use of systemic corticosteroids (nose drops, eye drops and/or inhalers are permitted) or other immunosuppressive drugs (e.g. cyclosporine A)
- Elevated values for vital signs: blood pressure: systolic above 160 mmHg, diastolic above 95 mmHg, pulse rate: above 100 beats/min
- Planned or scheduled subject surgery or hospitalisation during the course of the trial
- Previously randomized in this trial (only valid for subjects included after 01JUN2020)
- Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing.
- Subjects, who are inmates of psychiatric wards, prisons or state institutions.
- Participation in a clinical trial with investigational medicinal products within the last 30 days prior to the Day 1 and / or during this trial.
- Employees of the trial sites who are directly involved in this trial or employees of the Sponsor's company.
- If in the opinion of the Investigator the subject should not participate in the trial for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled, Dose-finding Multi-center, Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers With Androgenetic Alopecia
This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16 weeks in healthy male subjects with androgenetic alopecia.
Read the detailed description
This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16 weeks in healthy male subjects with androgenetic alopecia.
The trial will be performed at three centers in Germany. The aim of the trial is to determine the most efficacious dose of FOL-005 topical formulation based on efficacy dose trends. It is planned to randomize 220 subjects (with a ratio 1:1:1:1 FOL-005 0.1%; FOL-005 0.5%; FOL-005 1.5%; vehicle).
The trial consists of a screening period of up to three weeks and a treatment period of 16 weeks.
Eligible subjects will be randomized at Baseline (Day 1) and will apply the investigational products themselves at home once daily for 16 weeks. Subjects will return to the sites bi- weekly for check of compliance and assessment of local tolerability. At Day1, Day 84 and Day 112 subjects will be evaluated for hair growth parameters by TrichoLAB imaging. The end of the clinical trial for each individual subject is defined as the Final Visit at Day 112. In case of premature termination of a randomized subject an Early Termination (ET) visit should be performed.
- Conditions
- Androgenetic Alopecia
- Being tested
- Topical formulation
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical formulationDrug
Topical administration on the scalp once daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| FOL- 005 (0.1 %) | Experimental | topical formulation Receives: Drug: Topical formulation |
| FOL -005 (0.5 %) | Experimental | topical formulation Receives: Drug: Topical formulation |
| FOL -005 (1.5 %) | Experimental | topical formulation Receives: Drug: Topical formulation |
| Vehicle | Placebo comparator | topical formulation Receives: Drug: Topical formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total hair density at week 16
The change in total (terminal+vellus) hair density (hair count (n per cm²)) from Baseline to Day 112
Measured: 16 weeks
Secondary outcomes (6)
Change in total hair density at week 12
The change in total (terminal+vellus) hair density (hair count (n per cm²)) from Baseline to Day 84
Measured: 12 weeks
Change in terminal hair density at week 16
Comparisons of treatments on terminal hair density at week 16 based on relative differences to Baseline
Measured: 16 week
Change in vellus hair density at week 16
Comparisons of treatments on vellus hair density at week 16 based on relative differences to Baseline
Measured: 16 week
Change in telogen hair density at week 16
Comparison of the change from Baseline (Day 1) to week 16 in percentage of telogen hairs (number of telogen hairs /total number of hairs) for each IP separately
Measured: 16 weeks
Change in anagen hair density at week 16
Comparison of the change from Baseline (Day 1) to week 16 in percentage of anagen hairs (number of anagen hairs /total number of hairs) for each IP separately
Measured: 16 weeks
Safety parameters
Adverse events
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start24 Jun 2020
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Follicum AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH, Hair and Skin Institute, Charité, Berlin, Germany, CentroDerm GmbH
- Responsible party
- Sponsor
- Investigators
- Ulrike Blume-Peytavi, Principal investigator, Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774874
- Sponsor's protocol ID
- FCS-003
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled, Dose-finding Multi-center, Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT04774874
- Acronym / sponsor ID
- FCS-003
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Follicum ABIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH, Hair and Skin Institute, Charité, Berlin, Germany, CentroDerm GmbH
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 1 Mar 2021 (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.
This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16 weeks in healthy male subjects with androgenetic alopecia.
Detailed description
This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16 weeks in healthy male subjects with androgenetic alopecia.
The trial will be performed at three centers in Germany. The aim of the trial is to determine the most efficacious dose of FOL-005 topical formulation based on efficacy dose trends. It is planned to randomize 220 subjects (with a ratio 1:1:1:1 FOL-005 0.1%; FOL-005 0.5%; FOL-005 1.5%; vehicle).
The trial consists of a screening period of up to three weeks and a treatment period of 16 weeks.
Eligible subjects will be randomized at Baseline (Day 1) and will apply the investigational products themselves at home once daily for 16 weeks. Subjects will return to the sites bi- weekly for check of compliance and assessment of local tolerability. At Day1, Day 84 and Day 112 subjects will be evaluated for hair growth parameters by TrichoLAB imaging. The end of the clinical trial for each individual subject is defined as the Final Visit at Day 112. In case of premature termination of a randomized subject an Early Termination (ET) visit should be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FOL- 005 (0.1 %) | Experimental | Drug: Topical formulationtopical formulation |
| FOL -005 (0.5 %) | Experimental | Drug: Topical formulationtopical formulation |
| FOL -005 (1.5 %) | Experimental | Drug: Topical formulationtopical formulation |
| Vehicle | Placebo comparator | Drug: Topical formulationtopical formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male, aged 18-55 years
- Skin phototype II, III and IV according to Fitzpatrick's classification (Fitzpatrick et al. 1974)
- Androgenetic alopecia (AGA) classified according to Hamilton Norwood grade 3V, 4, 5, 5A, 5V (Hamilton, 1951)
- Willing and able to comply with scheduled visits
- Willing to maintain the same hair hygiene products and general hair care habits during the trial period
Key exclusion criteria (29 listed)
- Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test sites risking to interfere with investigational evaluations
- Any dermatological disorders of the scalp which might interfere with the application of the investigational product (IP) or examination method, such as fungal or bacterial infections, seborrheic dermatitis (except mild forms which are managed with OTC shampoos and which do not require dermatological treatment), psoriasis, eczema, folliculitis, that require chronic use of medication or scalp atrophy
- Any skin pathology (e.g. scar, nevus) or general condition (e.g. uncontrolled thyroid diseases) that in the Investigator's opinion can interfere with the evaluation of the test areas or requires prohibited topical or systemic therapy
- History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
- Diabetes mellitus
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 |
|---|---|---|
| Topical formulationTopical administration on the scalp once daily for 16 weeks | Drug | FOL -005 (0.5 %), FOL -005 (1.5 %), FOL- 005 (0.1 %), Vehicle |
Primary outcome
Change in total hair density at week 16
Time frame: 16 weeks
The change in total (terminal+vellus) hair density (hair count (n per cm²)) from Baseline to Day 112
6 secondary outcomes
Change in total hair density at week 12
Time frame: 12 weeks
Change in terminal hair density at week 16
Time frame: 16 week
Change in vellus hair density at week 16
Time frame: 16 week
Change in telogen hair density at week 16
Time frame: 16 weeks
Change in anagen hair density at week 16
Time frame: 16 weeks
Safety parameters
Time frame: 16 weeks
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 1 Mar 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.
Ulrike Blume-Peytavi principal investigator
Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical formulation in people with Androgenetic Alopecia, run by Follicum AB at 1 site in Germany.
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 29 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 1 Mar 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in total hair density at week 16 (time frame: 16 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 1 Mar 2021.