None listed
Conditions
Interventions
Intervention1: TediBar Ceramax Bathing Bar: A 0.04 mL of 8% w/v solution of test sample along
with negative controls will be
applied on the back of subjects
i.e. between the scapula and
waist through
Sponsors
Torrent Pharmaceutical 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 numbers of males and females). 3)Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application. 4) Subjects who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results. 5) Subjects in good general health as determined by the Investigator on the basis of medical history. 6)Subjects willing and able to follow the study directions, to participate in the study, returning for all specified visits. 7) Subjects must be able to understand and provide written informed consent to participate in the study. 8) Subjects willing to take bath using the same soap/cleansers during the study period. 9) Subjects willing to refrain from vigorous physical exercise during the study period.
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. 8) Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease). 9) Subjects with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous. 10) Individual who has a medical condition or is taking or has taken a medication which, in the Investigator s judgment, makes the subject ineligible or places the subject at undue risk. 11) Subject with known allergy or sensitization to medical adhesives, bandages. 12) Subjects has participation in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study. 13) Subject reports a history of skin sensitivity to shampoos and detergents or a known hypersensitivity and/or sensitization to medical adhesives. 14) Subjects reports use of systemic or topical antihistamines (at any site) or uses of topical drugs at patch site(s) within 72 hours prior to patch application. 15) Participation in other patch study simultaneously. 16) Use of any: i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application. ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application. iii. Systemic or topical corticosteroids at patch site within four (4) weeks of Test Product application (steroidal nose drops and/or eye drops are permitted). iv. Topical drugs used at application site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction phase: 1)To confirm that the test products are irritating or not when applied over a continuous 21-day period and to evaluate safety of test products Challenge phase 1)To evaluate the incidence of potential sensitization reactions observed for the test products and safety of test products Rechallenge phase 1) To evaluate the potential sensitization reaction of the test product if observed in challenge phase.Timepoint: After usage of the test product at Visit 03 to 11(day 03,3,5,7,9,11,13,15,17,19) Visit 13 to 15 (day 38 to 40) Visit 16 (Day 42) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed