Photosensitization Study in Androgenetic Alopecia

NCT02791243 | Completed Phase 1

• 1 other identifier: PM1542
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the potential for induction of photosensitization by P-3074 0.25% finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a negative control (0.9% sodium chloride, NaCl)

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Potential for induction of photosensitization

  from day 4 to day 42

Study Arms (3)

Finasteride 0.25%

EXPERIMENTAL

approximately 0.2 ml of P-3074 (0.25% finasteride)

Drug: Finasteride 0.25%

Placebo for Finasteride 0.25%

PLACEBO COMPARATOR

approximately 0.2 ml of the vehicle cutaneous solution

Drug: Placebo for Finasteride 0.25%

Negative Control

OTHER

approximately 0.2 ml of 0.9% aqueous NaCl

Drug: Negative Control

Interventions

Finasteride 0.25% DRUG

Cutaneous solution of finasteride 0.25%

Also known as: P-3074

Finasteride 0.25%

Placebo for Finasteride 0.25% DRUG

vehicle cutaneous solution of P-3074

Also known as: vehicle cutaneous solution

Placebo for Finasteride 0.25%

Negative Control DRUG

0.9% aqueous NaCl

Also known as: 0.9% aqueous NaCl

Negative Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged 18 to 65.
• Good general health, as assessed by verbal medical history and brief physical examination of the skin.
• Fitzpatrick Skin Type I-IV, determined by interview at screening.
• Willing to use a double-barrier methods (for example, a condom or a diaphragm plus spermicide) during sexual intercourse with a female partner while participating in the study.
• Male subjects will need to confirm method and length of time for method of birth control for female partners.
• Fully informed of the risks of entering the study and willing to provide written consent to enter the study.
• Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
• Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating on the study.

You may not qualify if:

• MED ≤ 2.5 SED for Fitzpatrick Skin Types I and II or MED ≤ 4.0 SED for Fitzpatrick Skin Types III and IV
• Type I Insulin-dependent diabetes
• Mastectomy for cancer involving removal of lymph nodes draining the test site.
• Clinically significant skin diseases which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active skin cancer.
• Use of any photosensitizing medications or supplements, such as but not limited to sulfa drugs, tetracyclines, phenothiazines, thiazides, antiemetics and St. John's Wort.
• Any medical conditions caused or affected by sunlight (UV), such as but not limited to solar urticarial and polymorphous light eruptions.
• Active immunologic disorders.
• Routine use of anti-inflammatory, immunosuppressive or antihistamine medications (81 mg aspirin is acceptable).
• Participation in a patch test or soap chamber test within the past 4 weeks.
• History of significant sensitivity or allergy to adhesive bandages, tapes, etc.
• Use of finasteride (oral and/or topical), within 6 months prior to the screening visit.
• Contraindications to finasteride therapy or intolerance of finasteride.
• History of sensitivity to skin solution products.
• Hair, tattoos, pigmentation, scars, moles or other conditions at the areas to be patched that may interfere with patch application, tolerability, or postapplication evaluations.
• Participation in a clinical trial or receipt of an investigational medication within 4 weeks of the study.

Sponsors & Collaborators

• Polichem S.A.: lead

Study Sites (1)

Princeton Consumer Research Inc.

Chelmsford, Essex, CM2 6UA, United Kingdom

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Carr, MD

  Princeton Consumer Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 6, 2016
• Study Start: May 9, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 27, 2016
• Last Updated: May 18, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)