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.
Conditions
Interventions
Trade Name: Hibiscrub (Colour Free)
Product Name: Hibiscrub
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: Chlorhexidine gluconate
CAS Number: 18472-51-0
Concentration unit: % (W/V) percen
Sponsors
Regent Medical
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed