To Assess Skin Safety of Test Product(s) by Patch Test on Adult Healthy Human Subjects
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovoBliss Research Pvt Ltd
About this trial
To Check Dermatological Safety of Test Products by 24 Hours Patch Testing
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 18-65 years (both inclusive) at the time of consent.
Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
Females of childbearing potential must have a self-reported negative pregnancy 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.
Subject having history of diabetes
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
Design model
Single group
Treatments tested in this trial
18 Test Products along with positive and negative control
Other intervention1\. Deep Hydration Gel 2. Anti-Wrinkle Gel 3. Anti-Aging Gel 4. Under Eye Cream 5. Brightening Cream 6. Moisturizing Cream 7. Anti-Acne Serum 8. Face Toner 9. Anti-Aging Toner 10. Clear Glow Toner 11. Super Anti-Aging Serum 12. Sun Screen SPF50 13. Anti-Pigmentation Serum 14. Super Cleansing Cream 15. Root Revive Hair Serum 16. Root Nourishment Hair Oil 17. Anti-Acne Face Wash 18. Ever Glow Face Wash 0.04 gm/ml 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
26 Participants
are divided into 1 treatment groupGroup A: 18 Test Products along with Positive and Negative ControlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Irritation Scoring at T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if neededSecondary outcomes
1
Safety of the skin
To evaluate the Safety of the skin by visual dermatological assessment by 0: No reaction and 4 Severe Reaction
Time frame
At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if requiredLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NovoBliss Research Pvt Ltd
Lead sponsor
Skin Harmony Lifescience Pvt. Ltd
Collaborator
Source ClinicalTrials.gov
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