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Photosensitization Study in Androgenetic Alopecia

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

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 6, 2016
Last Update Posted Date May 18, 2017
Actual Study Start Date  ICMJE May 9, 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Potential for induction of photosensitization [ Time Frame: from day 4 to day 42 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2016)
Skin Visual Assessment Scores [ Time Frame: from day 4 to day 42 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Photosensitization Study in Androgenetic Alopecia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2016)
Actual Study Completion Date  ICMJE June 27, 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02791243
Other Study ID Numbers  ICMJE PM1542
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Polichem S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Polichem S.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Carr, MD Princeton Consumer Research Inc.
PRS Account Polichem S.A.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP