Androgenic AlopeciaPhase 2NCT03467412
To Investigate Efficacy of FOL-005 on Hair Growth on Scalp Skin
A Phase 2 study testing FOL-005 in people with Androgenic Alopecia, run by Follicum AB at 2 sites in Germany.
Trial summary
The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial. 60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion. 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
- Androgenic Alopecia
- 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
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- 27 Feb 2018to 22 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Androgenetic alopecia (AGA)) - Norwood/Hamilton grade 3V to 4/4a
- Caucasian, skin type I - IV according to Fitzpatrick's classification
Who cannot join
- Any dermatological disorders of the scalp which might interfere with the application of Investigational Medical Product or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis 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 treatment areas or requires topical or systemic therapy
- History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
- Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
- Diabetes mellitus
- Coagulation deficiencies
Show all 18Show fewer
- Topical treatments for hair growth (minoxidil, anti-androgens or other agents known to affect hair growth) in the last 6 months
- Topical treatments of the scalp including corticosteroids, tacrolimus, retinoids in the last 2 months or other treatments that may affect hair growth
- Platelet rich plasma (PRP) treatment on scalp during the last 12 months
- Systemic therapy using retinoids, cyclosporine within the last 3 months
- Systemic treatment with beta blockers or corticosteroids, scalp procedures e.g. surgery, laser, light, micro-needling within the last 6 months
- Finasteride (e.g. Propecia®) or Dutasteride intake in the last 12 months, or any systemic hair therapy medication in the last 12 months
- History of any acute (e.g. acute infections) or chronic illness (e.g. psoriasis, atopic dermatitis, porphyria) or known skin cancer that in the opinion of the investigators might confound the results of the trial
- History or clinical signs of keloids or hypertrophic scars
- Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening
- Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifylline, nitroglycerine) or anticoagulating drugs (e.g. heparins, cumarins, new oral anticoagulants, regular intake of acetylsalicylic acid)
- Current or within 3 months prior to first dosing use of anti-inflammatory medication (ibuprofen, paracetamol is permitted), corticosteroids (nose drops, eye drops and/or inhalers are permitted) or immunosuppressive drugs taken for more than 2 consecutive weeks
- Hair transplantation at any time
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Berlin, 10117
Bioskin GmbH
Hamburg, 20095
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Phase 2 Trial of FOL-005 to Investigate Efficacy on Hair Growth on Scalp Skin in Healthy Volunteers
The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial.
60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion.
Read more
The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of dosing, three times per week. Each subject received two doses of the five trial treatment doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as intradermal injections. On each volunteer, two treatment areas were placed on the head and the two selected doses were allocated to the respective treatment areas according to the randomisation scheme. The treatment areas were selected on the border between the bald surface and the surface with hair.
The effect on hair growth was measured by the use of Trichoscan imaging and measuring method at week 8 and 12. A baseline measaure was taken at day 0.
- Conditions
- Androgenic Alopecia
- Being tested
- FOL-005, Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOL-005Drug
intradermal injection
PlaceboDrug
intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| 0.00625 μg FOL-005 | Experimental | 50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks. Receives: Drug: FOL-005 |
| 0.025 μg FOL-005 | Experimental | 50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks. Receives: Drug: FOL-005 |
| 0.050 μg FOL-005 | Experimental | 50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks. Receives: Drug: FOL-005 |
| 0.100 μg FOL-005 | Experimental | 50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks. Receives: Drug: FOL-005 |
| Placebo | Placebo comparator | 50 μl solution (placebo) injected intradermally three times per week for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scalp Hair Density
Change from baseline of total hair density (No. of hairs per cm"2") on the scalp
Measured: 12 weeks
Secondary outcomes (4)
Proportion of Anagen Hairs (%)
Change from baseline in proportion of anagen hairs (%) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)
Measured: From baseline to after 12 weeks treatment
Change in Proportion of Telogen Hairs (%)
Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of
Measured: From baseline to after 12 weeks treatment
Anagen Hair Density
Change from baseline of anagen hair density (number of hairs per cm"2") on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.
Measured: From baseline to after 12 weeks treatment
Change in Telogen Hair Density
Change from baseline of telogen hair density (number of hairs per cm2) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)
Measured: From baseline to after 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start27 Feb 2018
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Follicum AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Responsible party
- Sponsor
- Investigators
- Ulrike Blume-Peytavi, Professor, Principal investigator, Klinik für Dermatologie, Charité-Universitätsmedizin, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467412
- Sponsor's protocol ID
- FCS-002
- Other IDs
- 2017-003809-17, 2017
- Status last verified
- Sep 2020
- First submitted
- 5 Mar 2018
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Phase 2 Trial of FOL-005 to Investigate Efficacy on Hair Growth on Scalp Skin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03467412
- Acronym / sponsor ID
- FCS-002
- Conditions
- Androgenic Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Follicum ABIndustry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial.
60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion.
The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of dosing, three times per week. Each subject received two doses of the five trial treatment doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as intradermal injections. On each volunteer, two treatment areas were placed on the head and the two selected doses were allocated to the respective treatment areas according to the randomisation scheme. The treatment areas were selected on the border between the bald surface and the surface with hair.
The effect on hair growth was measured by the use of Trichoscan imaging and measuring method at week 8 and 12. A baseline measaure was taken at day 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.00625 μg FOL-005 | Experimental | Drug: FOL-00550 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks. |
| 0.025 μg FOL-005 | Experimental | Drug: FOL-00550 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks. |
| 0.050 μg FOL-005 | Experimental | Drug: FOL-00550 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks. |
| 0.100 μg FOL-005 | Experimental | Drug: FOL-00550 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks. |
| Placebo | Placebo comparator | Drug: Placebo50 μl solution (placebo) injected intradermally three times per week for 12 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male, aged 18-55 years
- Androgenetic alopecia (AGA)) - Norwood/Hamilton grade 3V to 4/4a
- Caucasian, skin type I - IV according to Fitzpatrick's classification
Key exclusion criteria (18 listed)
- Any dermatological disorders of the scalp which might interfere with the application of Investigational Medical Product or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis 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 treatment areas or requires topical or systemic therapy
- History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
- Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
- 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 |
|---|---|---|
| FOL-005intradermal injection | Drug | 0.00625 μg FOL-005, 0.025 μg FOL-005, 0.050 μg FOL-005, 0.100 μg FOL-005 |
| Placebointradermal injection | Drug | Placebo |
Primary outcome
Scalp Hair Density
Time frame: 12 weeks
Change from baseline of total hair density (No. of hairs per cm"2") on the scalp
4 secondary outcomes
Proportion of Anagen Hairs (%)
Time frame: From baseline to after 12 weeks treatment
Change in Proportion of Telogen Hairs (%)
Time frame: From baseline to after 12 weeks treatment
Anagen Hair Density
Time frame: From baseline to after 12 weeks treatment
Change in Telogen Hair Density
Time frame: From baseline to after 12 weeks treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Androgenic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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, Charité-Universitätsmedizin, Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOL-005 in people with Androgenic Alopecia, run by Follicum AB at 2 sites 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 3 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Scalp Hair Density (time frame: 12 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 3 Dec 2020.