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

Allergic Sensitization Clinical Trial

— RIPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450070
• Other study ID #: CO- 171028001439-SACT
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: December 22, 2017

Study information

• Verified date: May 2019
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patch Testing for device cream on human subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Sensitization

Intervention

Device:
• Light Therapy Mask Cream
test panel

Locations

Country	Name	City	State
United States	Harrison Research Laboratories	Union	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation	"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	approximately 6 weeks