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Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth

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ClinicalTrials.gov Identifier: NCT02793557
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Follicum AB

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertrichosis Alopecia Hirsutism Drug: FOL-005 Other: Placebo Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Trial of FOL-005 to Investigate Clinical Safety and Effect on Hair Growth in Healthy Volunteers
Study Start Date : January 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
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.
Other: Placebo
Experimental: FOL-005: Solution 1
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Drug: FOL-005
Intradermal injection of 50 μl solution

Experimental: FOL-005: Solution 2
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Drug: FOL-005
Intradermal injection of 50 μl solution

Experimental: FOL-005: Solution 3
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Drug: FOL-005
Intradermal injection of 50 μl solution

Experimental: FOL-005: Solution 4
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
Drug: FOL-005
Intradermal injection of 50 μl solution




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2 [ Time Frame: 3 months ]
  2. Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs [ Time Frame: 3 months ]
  3. Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male, aged 18-45 years
  • Clinically visible terminal hair growth on thighs

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793557


Locations
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Germany
Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Berlin, Germany, 10117
Sponsors and Collaborators
Follicum AB
Investigators
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Principal Investigator: Ulrike Blume-Peytavi, Professor Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin Charitéplatz 1 - 10117 Berlin

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Responsible Party: Follicum AB
ClinicalTrials.gov Identifier: NCT02793557     History of Changes
Other Study ID Numbers: FCS-001
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Alopecia
Hirsutism
Hypertrichosis
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Virilism
Signs and Symptoms
Pharmaceutical Solutions