Keratosis, Actinic Clinical Trial
Official title:
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
NCT number | NCT02594644 |
Other study ID # | 553703 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 6, 2014 |
Est. completion date | June 22, 2016 |
Verified date | October 2018 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
Status | Completed |
Enrollment | 32 |
Est. completion date | June 22, 2016 |
Est. primary completion date | June 22, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age and older - Subjects has actinic keratoses and qualifies for photodynamic therapy - Do not meet any of the exclusion criteria Exclusion Criteria: - Subjects who smoke - Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition - Subjects who have established allergy to topical ALA - Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months |
Country | Name | City | State |
---|---|---|---|
United States | University of California-Davis, Department of Dermatology | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in the Percentage of Complete Clearance of the Actinic Keratoses | The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups. | Baseline, 2 Months | |
Secondary | Visual Analog Pain Scale | The secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | Immediately Post-Treatment |
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