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

NCT05611593 | Recruiting Phase 1

• 1 other identifier: CSP-001-FOL1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (1)

• Safety of product application

  Adverse event reporting (local and general)

  28 weeks

Secondary Outcomes (1)

• Tolerability & Usability

  28 weeks

Other Outcomes (4)

• Change in hair count

  28 weeks

• Change in total hair density

  28 weeks

• Change in hair thickness

  28 weeks

Study Arms (2)

FOL100

EXPERIMENTAL

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

Drug: FOL100

Propecia 1mg (oral Finasteride)

ACTIVE COMPARATOR

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

Drug: Propecia 1Mg Tablet

Interventions

FOL100 DRUG

FOL100 lotion

FOL100

Propecia 1Mg Tablet DRUG

Oral Finasteride

Also known as: Oral Finasteride

Propecia 1mg (oral Finasteride)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent will be signed by the subject before starting any study related procedures.
• Male subject between the ages of 18 to 45 years old.
• Male subject with mild to moderate vertex male-pattern hair loss, classified as grade III vertex to V, 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.

You may not qualify if:

• 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 1 year for systemic use and 6 months for topical use: 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 6 months prior to enrollment for any topical medication that is considered to affect hair growth.
• Use of a therapeutic shampoo for hair loss 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.

Sponsors & Collaborators

• Follicle Pharma Ltd: lead

Study Sites (3)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Finasteride; Tablets

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Solli Brawer

  Follicle Pharma Ltd

  STUDY DIRECTOR

Central Study Contacts

Solli Brawer

CONTACT

+972747366444; info@folliclepharma.com

Offer Fabian

CONTACT

+972747366444; info@folliclepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Group Assignment

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 10, 2022
• Study Start: October 20, 2022
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)