Androgenic Alopecia
Conditions
Brief 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. 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.
Interventions
DRUGFOL-005
intradermal injection
DRUGPlacebo
intradermal injection
Sponsors
Bioskin GmbH
Follicum AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scalp Hair Density | 12 weeks | Change from baseline of total hair density (No. of hairs per cm2) on the scalp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Anagen Hairs (%) | From baseline to after 12 weeks treatment | 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.) |
| Change in Proportion of Telogen Hairs (%) | From baseline to after 12 weeks treatment | Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of |
| Anagen Hair Density | From baseline to after 12 weeks treatment | Change from baseline of anagen 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. |
| Change in Telogen Hair Density | From baseline to after 12 weeks treatment | 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.) |
Countries
Germany
Participant flow
Pre-assignment details
Each subject received 2 dose strengths on 2 separate areas locally applied on the scalp. Thus, 120 treatment areas were defined in the trial but only 60 subjects participated. The number of participants in each arms are not unique subjects since each subject will appear in 2 arms. The total number of participants in the trial is 60.
Participants by arm
| Arm | Count |
|---|---|
| Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment In total 60 subjects were recruited. Each subject received 2 treatments in parallell on 2 different treatment areas. Baseline characteristics can therefore not be described for the individual treatment groups as they refer to treatment areas and not subjects. Hence, baseline characteristics are only reported for the total number of recruited subjects, i.e. 60. | 60 |
| Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment In total 60 subjects were recruited. Each subject received 2 treatments in parallell on 2 different treatment areas. Baseline characteristics can therefore not be described for the individual treatment groups as they refer to treatment areas and not subjects. Hence, baseline characteristics are only reported for the total number of recruited subjects, i.e. 60. | 120 |
| Total | 180 |
Baseline characteristics
| Characteristic | Combined Baseline Presentation of All Randomised Patient Irrespective of Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age, Continuous | 39.4 years STANDARD_DEVIATION 9.8 |
| Height | 180.6 cm STANDARD_DEVIATION 6.7 |
| Region of Enrollment Germany | 60 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 60 Participants |
| Weight | 84.91 kg STANDARD_DEVIATION 14.88 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 20 | 0 / 60 |
| other Total, other adverse events | 4 / 25 | 8 / 25 | 4 / 25 | 6 / 25 | 5 / 20 | 18 / 60 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 20 | 0 / 60 |
Outcome results
Primary
Scalp Hair Density
Change from baseline of total hair density (No. of hairs per cm2) on the scalp
Time frame: 12 weeks
Population: Note: one subject receiving 0.00625 and 0.050 μg FOL-005 withdrew consent after treatment. Data for primary outcome were available and and consequently used. The nNumber of analysed subjects therefore exceeds number of completed subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.00625 μg FOL-005 | Scalp Hair Density | 1.46 Change from baseline (No. of hairs/cm2) | Standard Deviation 14.75 |
| 0.025 μg FOL-005 | Scalp Hair Density | 2.58 Change from baseline (No. of hairs/cm2) | Standard Deviation 15.36 |
| 0.050 μg FOL-005 | Scalp Hair Density | -4.10 Change from baseline (No. of hairs/cm2) | Standard Deviation 21 |
| 0.100 μg FOL-005 | Scalp Hair Density | 6.68 Change from baseline (No. of hairs/cm2) | Standard Deviation 22.24 |
| Placebo | Scalp Hair Density | 5.60 Change from baseline (No. of hairs/cm2) | Standard Deviation 16.71 |
Secondary
Anagen Hair Density
Change from baseline of anagen 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.00625 μg FOL-005 | Anagen Hair Density | -2.26 number of hairs per cm2 | Standard Deviation 28.89 |
| 0.025 μg FOL-005 | Anagen Hair Density | 3.65 number of hairs per cm2 | Standard Deviation 21.77 |
| 0.050 μg FOL-005 | Anagen Hair Density | -4.41 number of hairs per cm2 | Standard Deviation 24.85 |
| 0.100 μg FOL-005 | Anagen Hair Density | 5.79 number of hairs per cm2 | Standard Deviation 25.21 |
| Placebo | Anagen Hair Density | -2.31 number of hairs per cm2 | Standard Deviation 19.7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.00625 μg FOL-005 | Change in Proportion of Telogen Hairs (%) | 8.49 percentage of telogen hairs | Standard Deviation 31.36 |
| 0.025 μg FOL-005 | Change in Proportion of Telogen Hairs (%) | -0.05 percentage of telogen hairs | Standard Deviation 22.12 |
| 0.050 μg FOL-005 | Change in Proportion of Telogen Hairs (%) | 8.66 percentage of telogen hairs | Standard Deviation 34.71 |
| 0.100 μg FOL-005 | Change in Proportion of Telogen Hairs (%) | 2.21 percentage of telogen hairs | Standard Deviation 36.82 |
| Placebo | Change in Proportion of Telogen Hairs (%) | 14.60 percentage of telogen hairs | Standard Deviation 25.58 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.00625 μg FOL-005 | Change in Telogen Hair Density | 3.72 number of hairs per cm2 | Standard Deviation 18.65 |
| 0.025 μg FOL-005 | Change in Telogen Hair Density | -1.06 number of hairs per cm2 | Standard Deviation 16.33 |
| 0.050 μg FOL-005 | Change in Telogen Hair Density | 0.31 number of hairs per cm2 | Standard Deviation 16.39 |
| 0.100 μg FOL-005 | Change in Telogen Hair Density | 0.89 number of hairs per cm2 | Standard Deviation 22.15 |
| Placebo | Change in Telogen Hair Density | 7.91 number of hairs per cm2 | Standard Deviation 14.34 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.00625 μg FOL-005 | Proportion of Anagen Hairs (%) | -0.03 percentage of anagen hairs | Standard Deviation 15.68 |
| 0.025 μg FOL-005 | Proportion of Anagen Hairs (%) | 1.40 percentage of anagen hairs | Standard Deviation 11.43 |
| 0.050 μg FOL-005 | Proportion of Anagen Hairs (%) | -0.73 percentage of anagen hairs | Standard Deviation 14.23 |
| 0.100 μg FOL-005 | Proportion of Anagen Hairs (%) | 3.18 percentage of anagen hairs | Standard Deviation 15.16 |
| Placebo | Proportion of Anagen Hairs (%) | -3.08 percentage of anagen hairs | Standard Deviation 9.53 |