NCT03015103|Unknown
Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
SAF DER ASSESS
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SAF DER ASSESS
Sponsor study identifier
interventional
28
0 countries
N/A
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThe purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 29, 2016
Actual (reported)January 2017
Date type not reportedThis date has not been verified as actual or estimated.
January 9, 2017
Actual (reported)February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Photoirritation as measured through the use of dressings containing tested product and placebo
The photoirritation will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and radiated with UVA. That procedure occurs during the period of five days.
5 days
Photosensitization as measured through the use of dressings containing tested product and placebo
The photosensitization will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and radiated with UVA. That procedure occurs during the period of 32 days.
32 days
This study is designed as a single group assignment, because the 4 dressings (3 placebos and 1 containing the product) will be applied in all volunteers. This means that the region in which the tested product will be applied will be compared with the other placebo regions in the same volunteer.
All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
December 29, 2016
First Posted
January 9, 2017
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
Estimated (date passed)HRIPT for Collagen Dressing
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 9, 2017
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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