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CompletedNCT02791243Updated May 18, 2017

Photosensitization Study in Androgenetic Alopecia

A Phase 1 interventional study of Finasteride 0.25% and Placebo for Finasteride 0.25% in Androgenetic Alopecia, sponsored by Polichem S.A.. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-18.

Sponsored by Polichem S.A. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study 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)

Read the 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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Conditions studied

  • Androgenetic Alopecia
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In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 58 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Polichem S.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Finasteride 0.25%

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

    Drug: Finasteride 0.25%

  • Placebo comparator
    Placebo for Finasteride 0.25%

    approximately 0.2 ml of the vehicle cutaneous solution

    Drug: Placebo for Finasteride 0.25%

  • Other
    Negative Control

    approximately 0.2 ml of 0.9% aqueous NaCl

    Drug: Negative Control

Interventions

  • DrugFinasteride 0.25%

    Cutaneous solution of finasteride 0.25%

    Also known as: P-3074

  • DrugPlacebo for Finasteride 0.25%

    vehicle cutaneous solution of P-3074

    Also known as: vehicle cutaneous solution

  • DrugNegative Control

    0.9% aqueous NaCl

    Also known as: 0.9% aqueous NaCl

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What researchers measure

Primary outcomes

  1. Potential for induction of photosensitization

    Time frame: from day 4 to day 42

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Study locations

1 site
  • Princeton Consumer Research Inc.
    Chelmsford,, Essex CM2 6UA, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02791243
Lead sponsor
Polichem S.A.
Responsible party
Sponsor
First posted
Jun 6, 2016
Start date
May 9, 2016
Primary completion
Jun 2016
Completion
Jun 27, 2016
Last update
May 18, 2017

Study contacts

Michael Carr, MD
principal investigator · Princeton Consumer Research Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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