Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To evaluate the dermatological safety of the investigational products on healthy human subjects
Study Overview
Brief Summary
Study Objective:
The objective of this study is toevaluate the dermatological safety of the investigational products on healthyhuman subjects.
Study Population:
24 healthy human volunteers (Male andFemale 1:1) with Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).
Duration of study:
Approximately 9 days for eachvolunteer.
Test Site:
Between the scapula and waist of thesubjects, the test site should be free of pigmentation, pimple, hair, mole orany dermatological condition that can interfere with the reading.
Patch Application:
The loaded patch system is applied atthe test site of study subjects starting with the lower edge of the patchsystem and slowly pressing upwards till the top edge in order to squeeze outthe air.
Patch Methodology:
The patch will be kept for 24 hours.The patch will be removed after 24 hours. The test sites will be wiped with aclean tissue to remove any residue prior to evaluation. Dermatologist willvisually assess the skin condition of each test site at the followingfrequencies- 20-30 minutes’ post patch removal (0 hour reading), 24 hrs and 7days’ post patch removal as per Draize scoring system.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Subjects in age group
- •65 years (both the ages inclusive). 2.Healthy male & female subjects. 3.Subjects with Fitzpatrick skin type III to V. 4.Subjects willing to give a voluntary written informed consent. 5.Subjects willing to maintain the patch test in position for 24 hours. 6.Subject having not participated in a similar investigation in the past two weeks. 7.Subjects willing to come for regular follow up visits. 8.Subjects ready to follow instructions during the study period.
Exclusion Criteria
- •1.Infection, allergy on the tested area.
- •2.Skin allergy, antecedents or atopic subjects.
- •3.Athletes and subjects with history of excessive sweating.
- •4.Cutaneous disease which may influence the study result.
- •5.Subjects on oral corticosteroid.
- •6.Subjects participating in any other cosmetic or therapeutic trial.
- •7.Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
Outcomes
Primary Outcomes
To evaluate the dermatological safety of the investigational products on healthy human subjects
Time Frame: Approximately 9 days for each subject.
Secondary Outcomes
No secondary outcomes reported