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OpenTrials
Completed

NCT Number: NCT03450070

Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100

Patch Testing for device cream on human subjects

Completed

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Key information

Conditions

Allergic Sensitization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harrison Research Laboratories

Union, New Jersey, 07083, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or Female
  • 18+ years
  • Good health
  • Signed and datad Informed Consent
  • Signed and dated HIPAA

Exclusion criteria

  • On test at any other research lab or clinic
  • Known allergy or sensitivity to cosmetics or toiletries
  • Pre-existing other medical conditions
  • Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test
  • Chronic medication which could affect the outcome of the study
  • Known pregnant or nursing women
  • Cancer diagnosis within the past 5 years

Treatment and study plan

Light Therapy Mask Cream

Device

test panel

Primary outcomes

  1. Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation

    Time frame: approximately 6 weeks

    "Clinically Significant Dermal Irritation" refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) & then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant.

    Scoring System:

    0 = No visible reaction

    ± = Faint, minimal erythema

    • = Erythema
    • = Intense erythema
    • = Intense erythema, induration, vesicles
    • = Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining
    • = Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading
    • = No patch application and / or reading TR = Tape Reaction

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Industry

Registry information

Official study title

Repeat Insult Patch Testing (RIPT) APPENDIX I to HRL Standard Protocol #100

Acronym: RIPT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2018
Registry last updated
May 15, 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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