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Study to Evaluate Safety & Usability of a New Formulation for Male Androgenetic Alopecia

Primary Purpose

Androgenic Alopecia

Status
Recruiting
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
FOL100
Propecia 1Mg Tablet
Sponsored by
Follicle Pharma Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenic Alopecia

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent will be signed by the subject before starting any study related procedures. Male subject between the ages of 18 to 40 years old. Male subject with mild to moderate vertex male-pattern hair loss, classified as grade III vertex and IV, according to the modified Norwood/Hamilton Scale. Subject must be willing to maintain normal shampooing habits and products during the study. Fitzpatrick skin phototype classification of I-IV. Subjects will agree to maintain the same haircut and color throughout the study, with no significant changes that will interfere with study objectives, as determined by the investigator. Ability to understand and cooperate with the investigator and to comply with the requirements of the study protocol. Exclusion Criteria: Clinically significant abnormal skin findings on the scalp, which in the opinion of the investigator, could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders, or any other abnormality. Hair transplant surgery or hair weaving. Clinically significant and active physical illness that could interfere with study objectives or may risk patient safety as determined by the Investigator during screening. Ascertained or presumptive hypersensitivity to the active principle and/or any of the formulation ingredients; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of the investigator may affect subject safety or the outcome of the study. History of local infections of the skin or subcutaneous tissues of the head within 3 months prior to study enrollment. Clinically significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases, which in the opinion of the investigator may affect subject safety or the outcome of the study. Suspicion of malignancy, including prostate cancer. Subject whose sexual partner(s) is pregnant or plan to become pregnant. Concurrent use of systemic corticosteroids, topical corticosteroids in the area treated in the study, anabolic steroids, or over the counter "hair restorers". Use of any of the following products in the past year that may affect hair growth: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine ,benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents. Use of oral finasteride or dutasteride, within 18 months prior to enrollment and 12 months prior to enrollment for any topical medication that is considered to affect hair growth. Use of a therapeutic shampoo administered by a physician with prescription within 1 month prior to enrollment. Light or laser treatment of scalp within 3 months prior to enrollment. Unwilling to undergo a superficial ink marking on the scalp vertex during V0.

Sites / Locations

  • Rabin Medical CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FOL100

Propecia 1mg (oral Finasteride)

Arm Description

Subjects will apply FOL100 lotion topically in the defined treatment area.

Participants will receive1 tablet of Propecia 1mg (oral Finasteride) once daily (q.d)

Outcomes

Primary Outcome Measures

Safety
Adverse event reporting (local and general)

Secondary Outcome Measures

Tolerability & Usability
Subject self-assessment by questionnaire

Full Information

First Posted
October 19, 2022
Last Updated
November 3, 2022
Sponsor
Follicle Pharma Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05611593
Brief Title
Study to Evaluate Safety & Usability of a New Formulation for Male Androgenetic Alopecia
Official Title
A Phase-I, Open Label, Multi-Centre Clinical Study to Assess the Safety, Tolerability and Usability of FOL100 Lotion in Comparison to Oral Finasteride, for the Treatment of Androgenetic Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Follicle Pharma Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The CSP-001-FOL1 clinical study is aimed to investigate whether local topical administration of FOL100 lotion will be safe for the patient and will not cause local or systemic skin or other adverse events. It is also aimed at indicating effectiveness as compared with oral Finasteride 1mg. In this non-blinded study, each patient will choose his preferred arm (oral finasteride or FOL100 location). During the study, safety and efficacy will be measured as well as usability.
Detailed Description
The proposed clinical study aims to test the safety, tolerability and usability of FOL100 compared to the commercially available Finasteride 1mg Propecia in male subjects suffering from AA. Study endpoints: Primary Endpoint: Safety-AE(s) & SAE(s) incidence rate. Secondary Endpoint: Tolerability & usability collecting information on safety, tolerability & usability. Exploratory Endpoint: Efficacy Mean change in total, vellus and non-vellus hair count, total hair density, cumulative hair diameter and mean hair thickness in the target region. Global photographic assessments. Subject self-assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FOL100
Arm Type
Experimental
Arm Description
Subjects will apply FOL100 lotion topically in the defined treatment area.
Arm Title
Propecia 1mg (oral Finasteride)
Arm Type
Active Comparator
Arm Description
Participants will receive1 tablet of Propecia 1mg (oral Finasteride) once daily (q.d)
Intervention Type
Drug
Intervention Name(s)
FOL100
Intervention Description
FOL100 lotion
Intervention Type
Drug
Intervention Name(s)
Propecia 1Mg Tablet
Other Intervention Name(s)
Oral Finasteride
Intervention Description
Oral Finasteride
Primary Outcome Measure Information:
Title
Safety
Description
Adverse event reporting (local and general)
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Tolerability & Usability
Description
Subject self-assessment by questionnaire
Time Frame
28 weeks
Other Pre-specified Outcome Measures:
Title
Change in hair count
Description
Change in total hair count, vellus and non-vellus hair count per cm^2 as assessed by Phototrichogram
Time Frame
28 weeks
Title
Change in total hair density
Description
Change in total hair density per cm^2 as assessed by Phototrichogram
Time Frame
28 weeks
Title
Change in hair thickness
Description
Change in cumulative diameter and hair thickness per cm^2 as assessed by Phototrichogram
Time Frame
28 weeks
Title
Exploratory Endpoint: Efficacy - self-assess
Description
Subject self-assessment by questionnaire
Time Frame
28 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent will be signed by the subject before starting any study related procedures. Male subject between the ages of 18 to 40 years old. Male subject with mild to moderate vertex male-pattern hair loss, classified as grade III vertex and IV, according to the modified Norwood/Hamilton Scale. Subject must be willing to maintain normal shampooing habits and products during the study. Fitzpatrick skin phototype classification of I-IV. Subjects will agree to maintain the same haircut and color throughout the study, with no significant changes that will interfere with study objectives, as determined by the investigator. Ability to understand and cooperate with the investigator and to comply with the requirements of the study protocol. Exclusion Criteria: Clinically significant abnormal skin findings on the scalp, which in the opinion of the investigator, could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders, or any other abnormality. Hair transplant surgery or hair weaving. Clinically significant and active physical illness that could interfere with study objectives or may risk patient safety as determined by the Investigator during screening. Ascertained or presumptive hypersensitivity to the active principle and/or any of the formulation ingredients; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of the investigator may affect subject safety or the outcome of the study. History of local infections of the skin or subcutaneous tissues of the head within 3 months prior to study enrollment. Clinically significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases, which in the opinion of the investigator may affect subject safety or the outcome of the study. Suspicion of malignancy, including prostate cancer. Subject whose sexual partner(s) is pregnant or plan to become pregnant. Concurrent use of systemic corticosteroids, topical corticosteroids in the area treated in the study, anabolic steroids, or over the counter "hair restorers". Use of any of the following products in the past year that may affect hair growth: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine ,benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents. Use of oral finasteride or dutasteride, within 18 months prior to enrollment and 12 months prior to enrollment for any topical medication that is considered to affect hair growth. Use of a therapeutic shampoo administered by a physician with prescription within 1 month prior to enrollment. Light or laser treatment of scalp within 3 months prior to enrollment. Unwilling to undergo a superficial ink marking on the scalp vertex during V0.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Solli Brawer
Phone
+972747366444
Email
info@folliclepharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Offer Fabian
Phone
+972747366444
Email
info@folliclepharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Solli Brawer
Organizational Affiliation
Follicle Pharma Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Rabin Medical Center
City
Petah tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Martinez, MD
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Lyakhovitsky, MD
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Koren

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate Safety & Usability of a New Formulation for Male Androgenetic Alopecia

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