About this trial
To Check Dermatological Safety of Test Products by 24 Hours Patch Testing
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject scoring greater than 30 for Section 2 - Sensitive v/s Resistant skin in modified Dr Baumann's* skin type questionnaire.
Subject with sensitive skin as confirmed by Lactic Acid Stinging Test.
Disqualifiers
Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
Medication which may affect skin response and/or past medical history. 3) Subject having history of diabetes 4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
Trial design
Single group
Treatments tested in this trial
1)0.1% Pinorox® Cream 2)1% Pinorox® Cream 3)Base cream 4)Positive control 5)Negative control
Other intervention0.04 gm of each Test Products along with positive control (1% SLS) and negative controls will be applied on the back of subjects i.e. between the scapula and waist through finn chamber patch.
Treatment groups
Trial outcomes
Primary outcomes
To evaluate the dermatological safety of the test products by 24 Hours Patch Test
Dermatological safety of the test products by 24 Hours Patch Test will be evaluated by 0: No reaction and 4 Severe Reaction
Secondary outcomes
Safety of the skin
To evaluate the Safety of the skin by visual dermatological assessment by 0: No reaction and 4 Severe Reaction
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NovoBliss Research Pvt Ltd
Lead sponsor
Ambe Phytoextracts Pvt. Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options: