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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00695578 |
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Date of registration:
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09/06/2008 |
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Primary sponsor: |
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Public title:
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Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
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Scientific title:
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A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00695578 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Steve Feldman, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wake Forest University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject must give written consent.
- Subjects must be >50 years of age, male or female.
- Subjects must have had cryotherapy treatment of at least one AK's on each forearm in
the Dermatology Clinic.
Exclusion Criteria:
- Subjects age <50 years of age.
- Subjects with known allergy or sensitivity to topical Biafine or polysporin ointment.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for AK while
participating in the study.
- Subjects using other topical agent's glycolic acid products, alpha-hydroxy acid
products, retinoids and chemical peel agents in the treatment areas while on study.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Actinic Keratosis
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Intervention(s)
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Drug: Biafine
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Primary Outcome(s)
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The change of the target lesions from Baseline to or end of treatment in the IGA
[Time Frame: 4 weeks]
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Secondary ID(s)
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00000341
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31335
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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