None listed
Conditions
Interventions
Intervention1: 1 cm2 Diclofenac Diethylamine 100 mg Transdermal Patch: Dose: 1 1 cm Patch (1 cm2) Route of administration: Topical Mode of
usage: Products will be evaluated through the complete
occ
Sponsors
Novamed Laboratories Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18-65 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females). 3) Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale). 4) Females of childbearing potential must have a self-reported negative pregnancy test 5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results. 6) Subject is in good general health as determined by the Investigator on the basis of medical history. 7) Subjects is willing to maintain the test patches in designated positions for 24 Hours. 8) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 9) Subject must be able to understand and provide written informed consent to participate in the study. 10) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given. 11) For Sensitive Specific Skin Study Only: 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.
Exclusion criteria
Exclusion criteria: 1) 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. 2) 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. 5) Subject suffering from any active clinically significant skin diseases which may contraindicate. 6) Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer. 7) Participation in any patch test for irritation or sensitization within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety of the test product by 24 Hours Patch Test Under Complete Occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal, Sensitive and Combination)Timepoint: To evaluate the dermatological safety of the test product by 24 Hours Patch Test | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety of the test productTimepoint: Post patch removal of 30 mins, 24 hours & 168 hours | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed