To Assess Skin Safety of Test Product(s) by Patch Test on Adult Healthy Human Subjects.

ConditionNormal Skin
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 volunteers

Qualifiers

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

Design model

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 intervention

    0.04 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

26 Participants
are divided into 1 treatment group
Group A: 1)0.1% Pinorox® Cream 2)1% Pinorox® Cream 3)Base cream 4)Positive control 5)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 needed

Secondary 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 required

Other outcomes

Locations

This trial has no 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: