Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis
NCT ID: NCT02844777
Last Updated: 2023-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2016-07-15
2017-05-26
Brief Summary
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Detailed Description
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The purpose of the study is to determine whether once-daily application of VDA-1102 ointment for 28 days is effective and well-tolerated in the treatment of actinic keratosis of the face and scalp.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Excipeint alone
Placebo
200 mg applied once-daily for 28 days
5% VDA-1102
Active study medication
5% VDA-1102
200 mg applied once-daily for 28 days
10% VDA-1102
Active study medication
10% VDA-1102
200 mg applied once-daily for 28 days
Interventions
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Placebo
200 mg applied once-daily for 28 days
5% VDA-1102
200 mg applied once-daily for 28 days
10% VDA-1102
200 mg applied once-daily for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject is immunosuppressed
* Subject has used any of the following topical treatments in the Treatment Field: (1) topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or other topical treatments for AK or that might impact AK within 12 weeks of Screening.
* Subject has used systemic retinoid therapy within 6 months of Screening Visit.
18 Years
ALL
No
Sponsors
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Vidac Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Chaim M Brickman, MD
Role: STUDY_DIRECTOR
Vidac Pharma
Locations
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Therapeutics Clinical Research
San Diego, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VDA-CP-03
Identifier Type: -
Identifier Source: org_study_id
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