A 96 hour (4-application) patch test and TEWL assessment in healthy volunteers to investigate the comparative skin irritation potential of six antiseptics and two controls following cutaneous patch application. - Patch test for six antiseptics

• Conditions: This trial will be carried out on healthy volunteers. Patches containing 0.2mls of each test product will be used. Each volunteer will have a single patch per product and the patches will be removed every 23 hours for visual assessment of the patch sites. Volunteers will be patched for four consecutive days. If any of the patch sites develop a reaction the volunteer will not be re-patched with that particular test product.

• Registration Number: EUCTR2006-005649-12-GB
• Lead Sponsor: Regent Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Healthy subjects aged 18-65 years.
2.Sex: male or female.
3.Written informed consent.
4.Willingness to follow study requirements.

Are the trial subjects under 18? no
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. Pregnancy or lactation.
2. Inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only).
3. A current skin disease of any type at the test site (e.g. eczema, psoriasis).
4. A fever in the last 12 hours, prior to the first patch application.
5. Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.
6. History of malignant disease.
7. Insulin dependent diabetes.
8. Concurrent medication likely to affect the response to the test products or confuse the results of the study, i.e. routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids).
9. Known sensitivity to the treatment solutions or their constituents including patch materials.
10. Participation in a primary irritation patch test using the same site, in the last 28 days.
11. Sensitisation or questionable sensitisation in a Repeat Insult Patch Test (RIPT).

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 determine the irritancy potential of six antiseptics and their affect on the Transepidermal water loss (TEWL) from the skin.;Secondary Objective: ;Primary end point(s): The primary objective of this study is to determine the irritancy potential of six antiseptics and their affect on the TEWL from the skin.