Human 96 Hour Repeat Open Application Test for Assessment of Skin Irritatio

Phase 1

• Conditions: ot applicable (Healthy Volunteer Study)

• Registration Number: EUCTR2005-000704-14-GB
• Lead Sponsor: Stiefel Laboratories International Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-03
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male of 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)
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 of topical steriods
4. Use of any topical or systemic medication, immunisations, anti-inflammatory, immunosuppressive or anti-histamine drugs likely to interfere with the study
5. History of skin disease or allergy likely to interfere with the study or known sensitivity to the test products of their ingredients
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 study on the test sites at screeening
9. Employee of Sequani Clinical or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or siblings offspring) of an employee

Study & Design

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