Photosensitization Study in Androgenetic Alopecia

• ClinicalTrials.gov Identifier: NCT02791243
• Recruitment Status: Completed
• First Posted: June 6, 2016
• Last Update Posted: May 18, 2017
• Sponsor: Polichem S.A.
• Information provided by (Responsible Party): Polichem S.A.

Tracking Information

• First Submitted Date: June 1, 2016
• First Posted Date: June 6, 2016
• Last Update Posted Date: May 18, 2017
• Actual Study Start Date: May 9, 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 6, 2016): Potential for induction of photosensitization [ Time Frame: from day 4 to day 42 ]
• Original Primary Outcome Measures (submitted: June 1, 2016): Skin Visual Assessment Scores [ Time Frame: from day 4 to day 42 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Androgenetic Alopecia

Intervention

• Drug: Finasteride 0.25%
  Cutaneous solution of finasteride 0.25%
  Other Name: P-3074
• Drug: Placebo for Finasteride 0.25%
  vehicle cutaneous solution of P-3074
  Other Name: vehicle cutaneous solution
• Drug: Negative Control
  0.9% aqueous NaCl
  Other Name: 0.9% aqueous NaCl

Study Arms

• Experimental: Finasteride 0.25%
  approximately 0.2 ml of P-3074 (0.25% finasteride)
  Intervention: Drug: Finasteride 0.25%
• Placebo Comparator: Placebo for Finasteride 0.25%
  approximately 0.2 ml of the vehicle cutaneous solution
  Intervention: Drug: Placebo for Finasteride 0.25%
• Negative Control
  approximately 0.2 ml of 0.9% aqueous NaCl
  Intervention: Drug: Negative Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 14, 2016): 58
• Original Estimated Enrollment (submitted: June 1, 2016): 60
• Actual Study Completion Date: June 27, 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02791243
• Other Study ID Numbers: PM1542
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Polichem S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Polichem S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Carr, MD; Princeton Consumer Research Inc.

• PRS Account: Polichem S.A.
• Verification Date: May 2017