HypertrichosisPhase 1/2NCT02793557
Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth
A Phase 1/2 study testing FOL-005 in people with Hypertrichosis and Alopecia, run by Follicum AB at 1 site in Germany.
Trial summary
A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrichosis, Alopecia, Hirsutism
- What is being tested?
- FOL-005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Mar 2017
- Phase
- Phase 1/2
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, aged 18-45 years
- Clinically visible terminal hair growth on thighs
Who cannot join
- Damaged skin in or around test sites
- History of any acute (e.g. acute infections) or chronic illness or known skin cancer that might confound the results of the trial
- History or clinical signs of keloids or hypertrophic scars
- Immunological disorders such as alopecia areata, and systemic lupus erythematosus
- 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)
- Current or within 3 months prior to first dosing use of anti-inflammatory medication, corticosteroids or immunosuppressive drugs taken for more than 2 consecutive weeks
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- Current or within 3 months prior to first dosing use of medication with hair growth modifying properties like minoxidil, diazoxid, cyclosporine, antiandrogens
- Current or within 12 months prior to first dosing intake of anabolics or 5-alpha reductase inhibitors
- Current or within one week prior to first dosing use of any topical drugs on the legs
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Berlin, 10117
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial of FOL-005 to Investigate Clinical Safety and Effect on Hair Growth in Healthy Volunteers
A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.
Read the detailed description
SAD part:
A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3.
MD part:
In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly
Each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated.
- Conditions
- Hypertrichosis, Alopecia, Hirsutism
- Being tested
- FOL-005, Placebo
- Medical subject headings
- Hypertrichosis, Alopecia, Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOL-005Drug
Intradermal injection of 50 μl solution
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intradermal injection of 50 μl solution. One application in SAD part for each dosing occasion. 2 or 3 times weekly for 3 month in MD part. Receives: Other: Placebo |
| FOL-005: Solution 1 | Experimental | Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. Receives: Drug: FOL-005 |
| FOL-005: Solution 2 | Experimental | Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. Receives: Drug: FOL-005 |
| FOL-005: Solution 3 | Experimental | Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. Receives: Drug: FOL-005 |
| FOL-005: Solution 4 | Experimental | Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. Receives: Drug: FOL-005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects
Measured: 3 months
Secondary outcomes (3)
Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2
Measured: 3 months
Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs
Measured: 3 months
Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrichosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Follicum AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Blume-Peytavi, Professor, Principal investigator, Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin Charitéplatz 1 - 10117 Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793557
- Sponsor's protocol ID
- FCS-001
- Status last verified
- Jul 2017
- First submitted
- 16 May 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial of FOL-005 to Investigate Clinical Safety and Effect on Hair Growth in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02793557
- Acronym / sponsor ID
- FCS-001
- Conditions
- Hypertrichosis, Alopecia, Hirsutism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Follicum ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Jun 2016 (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.
A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.
Detailed description
SAD part:
A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3.
MD part:
In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly
Each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboIntradermal injection of 50 μl solution. One application in SAD part for each dosing occasion. 2 or 3 times weekly for 3 month in MD part. |
| FOL-005: Solution 1 | Experimental | Drug: FOL-005Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. |
| FOL-005: Solution 2 | Experimental | Drug: FOL-005Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. |
| FOL-005: Solution 3 | Experimental | Drug: FOL-005Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. |
| FOL-005: Solution 4 | Experimental | Drug: FOL-005Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male, aged 18-45 years
- Clinically visible terminal hair growth on thighs
Key exclusion criteria (9 listed)
- Damaged skin in or around test sites
- History of any acute (e.g. acute infections) or chronic illness or known skin cancer that might confound the results of the trial
- History or clinical signs of keloids or hypertrophic scars
- Immunological disorders such as alopecia areata, and systemic lupus erythematosus
- 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)
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 |
|---|---|---|
| FOL-005Intradermal injection of 50 μl solution | Drug | FOL-005: Solution 1, FOL-005: Solution 2, FOL-005: Solution 3, FOL-005: Solution 4 |
| Placebo | Other | Placebo |
Primary outcome
Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects
Time frame: 3 months
3 secondary outcomes
Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2
Time frame: 3 months
Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs
Time frame: 3 months
Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs
Time frame: 3 months
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 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertrichosis
RecruitingObservational study
Treatment of Hypertrichosis With Intense Pulsed Light
Hypertrichosis, Hirsutism - Hypertrichosis
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, Professor principal investigator
Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin Charitéplatz 1 - 10117 Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FOL-005 in people with Hypertrichosis and 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 2 inclusion and 9 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 Aug 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 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 combined 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.
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?
Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects (time frame: 3 months). 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 Aug 2017.