96 HOUR HUMAN PATCH TEST FOR ASSESSMENT OF PRIMARY SKIN IRRITATIO

Phase 1

• Conditions: ot Applicable (Healthy Volunteer Study)

• Registration Number: EUCTR2004-004829-97-GB
• Lead Sponsor: Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel International R&D)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Male or female
2. Aged 16-65 years
3. Willing and able to provide written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Females who are pregnant, breast-feeding or of child bearing potential who are not using a medically approved form of contraception
2. Any significant concurrent illness
3. Use of oral or topical steroids
4. Use of any prohibited medications as listed in section 3.6.2
5. History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients, or to the patch material.
6. Have received an investigational medicinal product or participated in any other test during the past 30 days
7. Concurrent participation in any other research study
8. Presence of irritated skin, tattoos, moles etc. on the test sites at screening
9. Employee of Sequani Clinical or Steifel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the primary skin irritation potential of CPO at three different concentrations of CPO (1.5%w/w, 1.0%w/w and 0.5%w/w), compared to Placebo Solution and Sterile Water.;Secondary Objective: ;Primary end point(s): The endpoint will be the mean primary irritation scores calculated from the individual gradings recorded by the assessor.