Photosensitization Study in Androgenetic Alopecia

Brief Title

Photosensitization Study in Androgenetic Alopecia

Official Title

A Within-subject, Randomized, Evaluator-blinded, Vehicle-controlled Study to Assess the Photosensitization Potential of Finasteride Cutaneous Solution(P-3074) in Human Subjects

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)
    

Detailed Description

      Healthy male volunteers, drawn from the general population, will be treated with P-3074
      solution, placebo vehicle control and 0.9% sodium chloride USP (negative control) by using 6
      induction applications on the back area and Ultraviolet A (UVA)/Ultraviolet B (UVB)
      irradiations during the 3 week induction period, a 10 day rest period, and a challenge phase
      of a 24-hour patch application, UVA and UVB irradiation followed by evaluation of
      photosensitization over the subsequent 72 hours.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Potential for induction of photosensitization

Condition

Androgenetic Alopecia

Intervention

Finasteride 0.25%

Study Arms / Comparison Groups

 Finasteride 0.25%

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

58

Start Date

May 9, 2016

Completion Date

June 27, 2016

Primary Completion Date

June 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Males aged 18 to 65.

          2. Good general health, as assessed by verbal medical history and brief physical
             examination of the skin.

          3. Fitzpatrick Skin Type I-IV, determined by interview at screening.

          4. 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.

          5. Male subjects will need to confirm method and length of time for method of birth
             control for female partners.

          6. Fully informed of the risks of entering the study and willing to provide written
             consent to enter the study.

          7. 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

          8. 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.

        Exclusion Criteria:

          1. MED ≤ 2.5 SED for Fitzpatrick Skin Types I and II or MED ≤ 4.0 SED for Fitzpatrick
             Skin Types III and IV

          2. Type I Insulin-dependent diabetes

          3. Mastectomy for cancer involving removal of lymph nodes draining the test site.

          4. Clinically significant skin diseases which may contraindicate participation, including
             psoriasis, eczema, atopic dermatitis, and active skin cancer.

          5. Use of any photosensitizing medications or supplements, such as but not limited to
             sulfa drugs, tetracyclines, phenothiazines, thiazides, antiemetics and St. John's
             Wort.

          6. Any medical conditions caused or affected by sunlight (UV), such as but not limited to
             solar urticarial and polymorphous light eruptions.

          7. Active immunologic disorders.

          8. Routine use of anti-inflammatory, immunosuppressive or antihistamine medications (81
             mg aspirin is acceptable).

          9. Participation in a patch test or soap chamber test within the past 4 weeks.

         10. History of significant sensitivity or allergy to adhesive bandages, tapes, etc.

         11. Use of finasteride (oral and/or topical), within 6 months prior to the screening
             visit.

         12. Contraindications to finasteride therapy or intolerance of finasteride.

         13. History of sensitivity to skin solution products.

         14. Hair, tattoos, pigmentation, scars, moles or other conditions at the areas to be
             patched that may interfere with patch application, tolerability, or postapplication
             evaluations.

         15. Participation in a clinical trial or receipt of an investigational medication within 4
             weeks of the study.

         16. Current treatment with allergy injections.

         17. History of severe asthma.

         18. Chronic or active liver disease [alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) > 1.5x upper limit of normal (ULN)]

         19. Neutrophils < 1500 cells/mm3

         20. Clinically significant chronic illness, which could place the subject at increased
             risk during participation or result in inappropriate dermal response during the study
             in the opinion of the Investigator.

         21. History of alcohol or drug abuse within 1 year of the study.

         22. Any condition the Investigator believes would interfere with the evaluation of the
             subject, or may put the subject at undue risk.

         23. Judged by the investigator to be unsuitable for any reason.
      

Gender

Male

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Michael Carr, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

NCT ID

NCT02791243

Organization ID

PM1542

Responsible Party

Sponsor

Study Sponsor

Polichem S.A.

Study Sponsor

Michael Carr, MD, Principal Investigator, Princeton Consumer Research Inc.

Verification Date

May 2017