None listed
Conditions
Interventions
Intervention1: GMTL 1, GMKL 2, GMVL 3, GMBM 4, GMHO 5, GMBR 6, GMPO 7, GMHW 8, GMCS 9, GMMS 10, GMPS 11, GMDS 12, GMCS 13, GMCM 14, GMGS 15, GMSG 017, GMBG 026: Topical Application
24 hours
To evaluat
Sponsors
Apex Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application. Subjects who have sensitive skin determined by the Dermatologist on basis of skin sensitivity questionnaires during screening visit. Subjects with positive reaction to lactic acid stinging test. Subjects who do not have any previous history of adverse skin conditions and are not under any medication. Subject with good general health as determined by the Investigator on the basis of medical history. Subjects willing to maintain the test patches in designated position for 24 hours. Subjects with Fitzpatrick skin type III to V. Subjects willing to give a voluntary written informed consent. Subject having not participated in a similar investigation in the past two weeks. Subjects without any open wounds, cuts, abrasions, irritation symptoms.
Exclusion criteria
Exclusion criteria: Female subject is pregnant, planning for pergnancy or lactating. Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimple marks, open wounds, sunburn, scars, tattoos, cuts, irritation symptoms. Medication which may affect skin response and/or past medical history. Subjects having history of diabetes. Subject suffering from any active clinically significant skin diseases which may contraindicate. Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer. Subjects having history of asthma or COPD (Chronic obstructivepulmonary disease). Subject with known allergy or sensitization to medical adhesives, bandages. Athletes and subjects with history of excessive sweating. Cutaneous disease which may influence the study result. Participation in other patch study simultaneously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Skin Condition will be evaluated for scoring after 30 Ã?± 5 minutes of patch removal, 24Ã?±2 hours of patch removal and 168Ã?±2 hours after the patch removal. Changes in Skin Irritation will be evaluated for scoring by asking well-being of subject after 30 Ã?± 5minutes of patch removal, 24Ã?±2 hours of patch removaland 168Ã?±2 hours after the patch removal.Timepoint: Day 01, 02, 03, 09 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of the subject by asking well-being of subject and Adverse event assessmentTimepoint: Day 01, 02, 03, 09 | — |
Countries
India
Contacts
Public ContactDr Senthurselvi
Spinos Lifescience and Research Pvt. Ltd.
Outcome results
None listed