A Phase 2 interventional study of FOL-005 and Placebo in Androgenic Alopecia, sponsored by Follicum AB. Completed at 2 sites in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-03.
Sponsored by Follicum AB · Phase 2, Interventional, and Treatment
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.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Follicum AB is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.
Drug: FOL-005
50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.
Drug: FOL-005
50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.
Drug: FOL-005
50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.
Drug: FOL-005
50 μl solution (placebo) injected intradermally three times per week for 12 weeks.
Drug: Placebo
intradermal injection
intradermal injection
Scalp Hair Density
Change from baseline of total hair density (No. of hairs per cm"2") on the scalp
Time frame: 12 weeks
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.)
Time frame: 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
Time frame: 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.
Time frame: 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.)
Time frame: From baseline to after 12 weeks treatment
| Milestone | 0.00625 μg FOL-005 | 0.025 μg FOL-005 | 0.050 μg FOL-005 | 0.100 μg FOL-005 | Placebo |
|---|---|---|---|---|---|
| Started | 25 | 25 | 25 | 25 | 20 |
| Completed | 22 | 24 | 20 | 23 | 17 |
| Not completed | 3 | 1 | 5 | 2 | 3 |
Change from baseline of total hair density (No. of hairs per cm"2") on the scalp
| Change from baseline (No. of hairs/cm2) | 0.00625 μg FOL-005 | 0.025 μg FOL-005 | 0.050 μg FOL-005 | 0.100 μg FOL-005 | Placebo |
|---|---|---|---|---|---|
| Scalp Hair Density | 1.46 ± 14.75 | 2.58 ± 15.36 | -4.10 ± 21.00 | 6.68 ± 22.24 | 5.60 ± 16.71 |
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.)
| percentage of anagen hairs | 0.00625 μg FOL-005 | 0.025 μg FOL-005 | 0.050 μg FOL-005 | 0.100 μg FOL-005 | Placebo |
|---|---|---|---|---|---|
| Proportion of Anagen Hairs (%) | -0.03 ± 15.68 | 1.40 ± 11.43 | -0.73 ± 14.23 | 3.18 ± 15.16 | -3.08 ± 9.53 |
Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of
| percentage of telogen hairs | 0.00625 μg FOL-005 | 0.025 μg FOL-005 | 0.050 μg FOL-005 | 0.100 μg FOL-005 | Placebo |
|---|---|---|---|---|---|
| Change in Proportion of Telogen Hairs (%) | 8.49 ± 31.36 | -0.05 ± 22.12 | 8.66 ± 34.71 | 2.21 ± 36.82 | 14.60 ± 25.58 |
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.
| number of hairs per cm2 | 0.00625 μg FOL-005 | 0.025 μg FOL-005 | 0.050 μg FOL-005 | 0.100 μg FOL-005 | Placebo |
|---|---|---|---|---|---|
| Anagen Hair Density | -2.26 ± 28.89 | 3.65 ± 21.77 | -4.41 ± 24.85 | 5.79 ± 25.21 | -2.31 ± 19.70 |
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.)
| number of hairs per cm2 | 0.00625 μg FOL-005 | 0.025 μg FOL-005 | 0.050 μg FOL-005 | 0.100 μg FOL-005 | Placebo |
|---|---|---|---|---|---|
| Change in Telogen Hair Density | 3.72 ± 18.65 | -1.06 ± 16.33 | 0.31 ± 16.39 | 0.89 ± 22.15 | 7.91 ± 14.34 |
Collected over 12 weeks. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.00625 μg FOL-005 | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| 0.025 μg FOL-005 | 0/25 (0%) | 0/25 (0%) | 8/25 (32%) |
| 0.050 μg FOL-005 | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| 0.100 μg FOL-005 | 0/25 (0%) | 0/25 (0%) | 6/25 (24%) |
| Placebo | 0/20 (0%) | 0/20 (0%) | 5/20 (25%) |
| Systemic Adverse Events | 0/60 (0%) | 0/60 (0%) | 18/60 (30%) |
| Event | 0.00625 μg FOL-005 | 0.025 μg FOL-005 | 0.050 μg FOL-005 | 0.100 μg FOL-005 | Placebo | Systemic Adverse Events |
|---|---|---|---|---|---|---|
| Skin exfoliationSkin and subcutaneous tissue disorders | 3/25 | 3/25 | 1/25 | 4/25 | 4/20 | 0/60 |
| NasopharyngitisInfections and infestations | 0/25 | 0/25 | 0/25 | 0/25 | 0/20 | 10/60 |
| HeadacheNervous system disorders | 0/25 | 0/25 | 0/25 | 0/25 | 0/20 | 5/60 |
| Influenza like illnessGeneral disorders | 0/25 | 0/25 | 0/25 | 0/25 | 0/20 | 5/60 |
| Application site exfoliationGeneral disorders | 1/25 | 2/25 | 2/25 | 2/25 | 0/20 | 0/60 |
| Rash pustularInfections and infestations | 0/25 | 2/25 | 0/25 | 1/25 | 1/20 | 0/60 |
| Rash pustularInfections and infestations | 0/25 | 0/25 | 0/25 | 0/25 | 0/20 | 4/60 |
| DiarrhoeaGastrointestinal disorders | 0/25 | 0/25 | 0/25 | 0/25 | 0/20 | 3/60 |
| Application site eczemaGeneral disorders | 0/25 | 0/25 | 1/25 | 0/25 | 0/20 | 0/60 |
| Application site pustulesInfections and infestations | 1/25 | 0/25 | 1/25 | 0/25 | 0/20 | 0/60 |
In total 60 subjects were recruited. However, each subject received 2 treatments which leads up to the total number of subjects appears to be twice as many, i.e. 120. Baseline characteristics only reported for the total number of recruited subjects, i.e. 60.
| Age, Categorical(Participants) | Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 60 |
| >=65 years | 0 |
| Age, Continuous(years) | Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment |
|---|---|
| Mean | 39.4 ± 9.8 |
| Sex: Female, Male(Participants) | Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment |
|---|---|
| Female | 0 |
| Male | 60 |
| Race and Ethnicity Not Collected(Participants) | Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment |
|---|
| Region of Enrollment(participants) | Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment |
|---|---|
| Germany | 60 |
| Weight(kg) | Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment |
|---|---|
| Mean | 84.91 ± 14.88 |
| Height(cm) | Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment |
|---|---|
| Mean | 180.6 ± 6.7 |
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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