At a glance
ClinicalIndex Comparison RecordN/ACompleted· 58 enrolled
Drug / intervention
Test Article +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 6-Week, Randomized, Evaluator-Blinded, In Vivo Within Subject Repeat Test to Evaluate the Irritation and Sensitization Potential of Omeza Collagen Matrix in Healthy Volunteers
In Brief
A clinical study evaluating Test Article and Negative Control for Erythema and Sensitisation. Completed, enrolled 58 participants across 1 site.
Detailed Summary
The primary objective of this study was to assess the sensitization potential of Omeza Collagen Matrix compared to that of a negative control based on a Modified Human Repeat Insult Patch Test.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErythema, Sensitisation
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartDec 2019
Primary CompletionJan 2020
First PostedAug 2020
TodayJul 2026
First PostedAug 12, 2020
Enrollment StartDec 2, 2019
Primary CompletionJan 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 5.9 years ago
Interventions
Test Articledevice
Omeza Collagen Matrix
Negative Controlother
Occlusive Patch of 0.9% sodium chloride, NaCl