50 Human Subject Repeat Insult Patch Test (HRIPT)

C

CAGE Bio

Status

Completed

Conditions

Erythema
Sensitisation

Treatments

Other: CB-0002B

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT04498676
MS17.RIPT.P1200O.50.CBIO

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

21 to 67 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Test product
Experimental group
Treatment:
Other: CB-0002B

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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