None listed
Conditions
Interventions
Intervention1: Test Product 1 HAPT-042207 (Patches): 0.2g of test product will be dispensed via pipette directly in the center webril pad of the semi occlusive patch. Patch will be applied immediately
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18-50 years (both inclusive) at the time of consent 2) Sex: Healthy male or non-pregnant/non-lactating females. 3) Female of childbearing potential must have a negative urine pregnancy test performed on screening visit. 4) Subject is in good general health as determined by the Investigator on the basis of medical history. 5) Subject with presence of prominent follicular orifices and the ability to form comedones on the upper part of the back (shoulder area). 6)Subjects willing to maintain the test patches on designated application sites for consecutive 28 days (4 weeks). 7) The Subjects willing to give written informed consent and willing to follow study procedure. 8) Subject are willing and able to make all evaluation visits and follow the protocol instructions. 9) Subject willing to refrain from vigorous physical exercise during the study period.
Exclusion criteria
Exclusion criteria: 1) Subjects who do not have presence of prominent follicular orifices and not have ability to form comedones on the upper part of back. 2) Subject has damaged skin in or around application sites, tattoos, scars, excessive hair, moles, burn marks/ scars or other disfiguration of the application sites. 3) Medical past and present history of significant dermatologic diseases or conditions, such as atopy, psoriasis, eczema, atopic dermatitis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes. 4)History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the patch application site. 5) Presence of open sores or other skin abnormalities at the application site. 6) History of skin allergy to adhesive tapes, adhesive materials or with other medications, cosmetics, toiletries, fragrances, topical skin products or other dermatological products. 7) Subject have used an active topical or systemic acne medication in the previous two weeks. 8) Have significant diseases or clinically significant abnormal findings during screening (brief medical history, abbreviated physical examination, and laboratory evaluations). 9)Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system. 10)History of presence of bronchial asthma. 11) Uses of any topical products (except soap) at application site prior to 24 hours of patch application. 12) Routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamines medications, antibiotics, retinoids, or exfoliative agents (steroid nose drops and/or eye drops are permitted) within 72 hrs prior to patch application. 13)Subject has a 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. 14)Show evidence of dermatological diseases or have a history of sun hypersensitivity and photosensitive dermatoses. 15) Have active acne vulgaris over the upper back. 16) Subject with positive hepatitis-self reported (subtypes B). 17) Subject with known history of positive HIV. 18) Pregnant or lactating females. 19) Participation in any clinical study or transdermal/topical patch study with active drug OR any patch study at the same application site within the last four weeks prior to patch application. 20) Be an employee of the sponsor or the site conducting the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine comedogenicity of the test product - if score is 1-3 in one or more subjectsTimepoint: Change from Baseline Visit 1 i.e. Day 01 to visit 14 i.e. Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be determined in terms of occurrence of adverse events & serious adverse eventsTimepoint: Change from Baseline Visit 1 i.e. Day 01 to visit 14 i.e. Day 28;To determine the degree of microcomedone of test products in terms of a percentageTimepoint: Change from Baseline Visit 1 i.e. Day 01 to visit 14 i.e. Day 28 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Pvt Ltd
Outcome results
None listed