None listed
Conditions
Interventions
Intervention1: Sun Chem Oxygen Bleach: Mode of Usage - The measuring spoon has 2 measurements, one is small and the other is big. Fill the activator powder in a small cup and fill the lotion in a
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Sponsors
Sun Chem India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 65 years (both inclusive) old at the time of consent. 2) Sex: Healthy adult 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 negative urine pregnancy test performed on Day 01 before application, and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc. 5) Subjects are generally in good general health as determined from recent medical history. 6) The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results. 7) The subject is in good general health as determined by the Investigator based on medical history. 8) The subjects who have not waxed their limbs for more than 20 days and who regularly wax their limbs. 9) The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits. 10) The subject must be able to understand and provide written informed consent to participate in the study. 11) The subject is willing to refrain from vigorous physical exercise during the study period and follow all the instructions given.
Exclusion criteria
Exclusion criteria: 1) The subject has skin irritation, blemishes, 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) The subject has a history of diabetes 4) The subject has a 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) The subject suffering from any active clinically significant skin diseases which may contraindicate. 6) The subject has a 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) The subject has a history of asthma or COPD (Chronic obstructive pulmonary disease). 9) Use of any: i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days before application. ii. Antihistamine medication or immunosuppressive drugs within seven (7) days before the 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) 10) Topical drugs used at the application site. 11) Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus. 12) An individual who has a medical condition or is taking or has taken a medication which, in the Investigatorââ?¬•s judgment, makes the subject ineligible or places the subject at undue risk. 13) Subject with known allergy or sensitization to medical adhesives, and bandages. 14) Participation in other clinical studies simultaneously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of Oxygen Bleach on self-timing, lighten hair/skin within xx minutes in a single application in healthy adult human subjects. 2. To evaluate the effectiveness of Liposoluble Wax in terms of complete removal of hair from the root, no pain, dirt and tan removal, no signs of itching, redness, burning, papular response, multi-directional hair removal on the skin in comparison with marketed Lipo wax in healthy adult human subjects. 3. To evaluate the safety of the test productsTimepoint: For Oxygen Bleach - Effectiveness on Day 1 & scoring at 30 min & 24 hour post product removal For Liposoluble Wax - From baseline to Day 1 and Day 2 (post product removal) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of test Product in terms of product perception from the Baseline on Day 01 before application and after application of test products.Timepoint: For Oxygen Bleach - Subjective Perception Questionnaire on Day 1. For Liposoluble wax - Subjective perception questionnaires on the sensorial evaluations on Day 1. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed