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OpenTrials
Completed

NCT Number: NCT03474874

Human Repeated Insult Patch Test

Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin

Completed

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consumer Product Testing Company, Inc.

Fairfield, New Jersey, 07004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults;
  • Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement;
  • Subjects must be considered dependable and able to follow directions

Exclusion criteria

  • Subjects who are in ill health;
  • Subjects who are taking medications other than birth control;
  • Female subjects who are pregnant (return positive urine pregnancy test), planning to become pregnant or lactating during the course of the trial;
  • Subjects who have a history of adverse reactions to personal care products, or known sensitivity to the test materials or their constituents including patch materials;
  • Subjects with any active skin disease;
  • Subjects who have heavy alcohol consumption;
  • Subjects with current use or history of repeated use of street drugs;
  • Subjects with a significant past medical history to potentially effect results of study;
  • Subjects with immunization less than 10 days prior to the test patch application;

Treatment and study plan

NeoMatriX Collagen Dressing

Device

Collagen wound dressing

Primary outcomes

  1. Erythema at the Patch Test Site is Evaluated for Each Participant

    Time frame: 3 weeks

    Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.

Secondary outcomes

  1. Sensitization Reactions

    Time frame: 5 weeks

    Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.

    Allergic Dermal Sensitization Potential - Erythema will be evaluated at the patch site for only the test material (positive and negative control will not be evaluated). Sensitization reactions will be determined at the patch test site after a two week rest period for each participant (similar to a "wash-out period"). The patch test site will be tested on the same study subject population, but using a virgin test site.

Sponsors and collaborators

Lead sponsor

NeXtGen Biologics, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2018
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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