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OpenTrials
Completed

NCT Number: NCT04498676

50 Human Subject Repeat Insult Patch Test

Consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for evaluation of this irritation/sensitization potential if such exists.

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Key information

Conditions

Erythema Pathological Conditions, Signs and Symptoms Sensitisation Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

21 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMA Laboratories Inc.

New City, New York, 10956, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals who are not currently under a doctor's care
  • Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the Investigator.
  • Individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation.
  • Individuals who will complete a preliminary medical history form mandated by AMA Laboratories, Inc. and are in general good health.
  • Individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing. Consent forms are kept on file and are available for examination on the premises of AMA Laboratories, Inc. only.
  • Individuals able to cooperate with the Investigator and research staff, willing to have test materials applied according to the protocol, and complete the full course of the study.

Exclusion criteria

  • Individuals under 18 years of age.
  • Individuals who are currently under a doctor's care.
  • Individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results.
  • Subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
  • Individuals diagnosed with chronic skin allergies.
  • Female volunteers who indicate that they are pregnant or lactating.

Treatment and study plan

CB-0002B

Other

CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid

Primary outcomes

  1. Erythema

    Time frame: 21 days

    Erythema rated on a numeric scale from 0 - 4. (0: None; 1: Minimal; 2: Mild; 3: Marked and 4: Severe erythema)

  2. Sensitisation

    Time frame: 24 hours

    After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4

  3. Sensitisation

    Time frame: 48 hours

    After a 10-14 day rest period, a challenge test was given at a different skin site to look for signals of a sensitization response measured by rating erythema on a scale from 0 - 4

Sponsors and collaborators

Lead sponsor

CAGE Bio Inc.

Industry

Collaborators

  • AMA Laboratories, Inc.

Registry information

Official study title

50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)

Acronym: HRIPT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2020
Registry last updated
Aug 4, 2020

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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