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
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|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Drug: Finasteride 0.25% Drug: Placebo for Finasteride 0.25% Drug: Negative Control||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
approximately 0.2 ml of 0.9% aqueous NaCl
Drug: Negative Control
0.9% aqueous NaCl
Other Name: 0.9% aqueous NaCl
- Potential for induction of photosensitization [ Time Frame: from day 4 to day 42 ]
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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|
- 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.
- 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.
- Current treatment with allergy injections.
- History of severe asthma.
- Chronic or active liver disease [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5x upper limit of normal (ULN)]
- Neutrophils < 1500 cells/mm3
- 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.
- History of alcohol or drug abuse within 1 year of the study.
- Any condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk.
- Judged by the investigator to be unsuitable for any reason.
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
|Princeton Consumer Research Inc.|
|Chelmsford,, Essex, United Kingdom, CM2 6UA|
|Principal Investigator:||Michael Carr, MD||Princeton Consumer Research Inc.|
|Responsible Party:||Polichem S.A.|
|Other Study ID Numbers:||
|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|
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