Human Repeat Insult Patch Test with Challenge
- Conditions
- ot Applicable (Healthy Volunteer Study)
- Registration Number
- EUCTR2004-004830-15-GB
- Lead Sponsor
- Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel International R&D)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
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) yes
F.1.3.1 Number of subjects for this age range
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 the patch material (Webril®/Blenderm®)
6. Participation in a repeat insult patch test during the previous 12 weeks
7. Participation in any other research study on the same skin site during the previous 4 weeks
8. Participation in any patch test involving the same skin site in the last 4 to 12 weeks where the skin irritation reactions have not yet completely cleared
9. Concurrent participation in any other research study
10. Presence of irritated skin, tattoos, scars or birthmarks at the test site at screening
11. Employee of Sequani Clinical or Stiefel 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
- Secondary Outcome Measures
Name Time Method