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Photosensitization Study in Androgenetic Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02791243
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Polichem S.A.

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)

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: Finasteride 0.25% Drug: Placebo for Finasteride 0.25% Drug: Negative Control Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 27, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Finasteride

Arm Intervention/treatment
Experimental: Finasteride 0.25%
approximately 0.2 ml of P-3074 (0.25% finasteride)
Drug: Finasteride 0.25%
Cutaneous solution of finasteride 0.25%
Other Name: P-3074

Placebo Comparator: Placebo for Finasteride 0.25%
approximately 0.2 ml of the vehicle cutaneous solution
Drug: Placebo for Finasteride 0.25%
vehicle cutaneous solution of P-3074
Other Name: vehicle cutaneous solution

Negative Control
approximately 0.2 ml of 0.9% aqueous NaCl
Drug: Negative Control
0.9% aqueous NaCl
Other Name: 0.9% aqueous NaCl




Primary Outcome Measures :
  1. Potential for induction of photosensitization [ Time Frame: from day 4 to day 42 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791243


Locations
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United Kingdom
Princeton Consumer Research Inc.
Chelmsford,, Essex, United Kingdom, CM2 6UA
Sponsors and Collaborators
Polichem S.A.
Investigators
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Principal Investigator: Michael Carr, MD Princeton Consumer Research Inc.

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Responsible Party: Polichem S.A.
ClinicalTrials.gov Identifier: NCT02791243    
Other Study ID Numbers: PM1542
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Photosensitivity Disorders
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Finasteride
Pharmaceutical Solutions
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents