A Clinical Study to assess the safety and efficacy of kanaka taila for its anti wrinkle and skin brightening effect in healthy volunteers

IntroductionHealthy skin showcase not only the overall physical health of theindividual but also has the positive impact on the self esteem of theindividual.Skin aging is a complex biological phenomenon consisting of twoindependent clinically and biologically distinct processes, namely “intrinsicaging†and “extrinsic aging.†Extrinsic aging (including “photoagingâ€) is theresult of exposure to outdoor elements, primarily ultraviolet (UV)irradiation. Photoaged skin shows a variety of age-associated clinicalalterations, including deep wrinkles, sallow discoloration, and irregularpigmentation. Recently, it has been revealed that reactive oxygen species(ROS) produced excessively in the cells are involved in the process of skinaging caused by UV exposure.Ayurveda provides various solutions to these conditions in form of certaintopical formulations.Kanak taila is a classical preparation mentioned in kshudra rogadhikar ofChakradatta.iThis tail is indicated in conditions of vali (wrinkles) and for improvement ofoverall skin tone .Present study aims to Evaluate and Document the Efficacy and Safety oflocal application of kanak taila in treatment of wrinkles and for skinwhitening .Test DrugKanaka Taila- Oil will be prepared and provided by Ozone PharmaceuticalLtd.This oil will be analyzed in a NABL accredited laboratory for variousphysiochemical parameters relating to its identity, Purity and Strength .Test DrugIngredientsCompositionS.No Ingredients Botanical Name Part to beUsed1. Madhuk Madhuka indica heartwood2. priyangu Callicarpa macrophylla flowers3. manjishtha Rubia cordifolia roots4. chandan Santanalum album heartwood5. Utpal Nelumbo nucifera flowersPage 3 of 146. kesar Crocus sativus stigma7. Til Sesamum indicum Seed oil

Study Designï‚· Single arm , prospective, open label, clinical trialï‚· Home use: two times per day; 7 days per weekï‚· Duration of Treatment : 8 weeksï‚· Study visits: Baseline, 4 and 8 weeksï‚· Clinical assessments: Baseline, 4 and 8 weeksï‚· Tolerability : Baseline, 4 and 8 week

MethodologyFor the proposed work Ethical clearance will be taken from InstitutionalEthical Committee NIA, Jaipur. And trial will be registered in CTRI, NewDelhio After registration in CTRI, 50 apparently healthy individuals fulfillingthe inclusion criteria will be recruited for the study at O.P.D. basis inNIA Arogyashala. 50 subjects will be selected on screening visit and awritten informed consent will be taken from subjects for theirparticipation in the study. Subjects will be instructed not to wear anyfacial makeup or apply any skin care products or sunscreen on the faceand neck on the day of the baselinevisit. On the Baseline visit afteracclimatization of 15 min, sides and front photograph will be taken. Page 5 of 14Baseline Grading of fine lines will be done according to the AllerganFine Lines Scale (grade 0 to 4). Skin whitening and smoothening at thetest site and improvement in fine lines will be evaluated subjectively bythe investigator and by the subjects on 0 to 3 scale. Baseline scoring forTolerance and Safety will be done on 0 – 3 point assessment scale(Erythema, edema, scaling,dryness by investigator & , burning, stinging& itching by Subject himself).o For the day of the 4 and 8 week visits subject will also be instructed toapply the study facial cream at least 2 hours prior to the study visits. Theywill also be instructed to discontinue using all of their current skin careproducts such as serums and moisturizers except the study product for theduration of the treatment with test drug. The study drug will be used athome twice per day for the 8 week duration of the study.o At each Follow up, subject will be given 15 minute acclimation periods,product use will be discussed. Documentation of adverse events andprotocol deviation will be done.AssessmentParameters Photographs at baseline, 4, & 8 weeks: Expert clinical grading (face):o Face (cheeks): Allergan Fine Lines Scale (grade 0 to 4)o Skin whitening and smoothening at the test site and improvement in finelines will be evaluated subjectively by the investigator and by the subjectson 0 to 3 scale. ii Tolerance (0 – 3 point assessment scale)iii:Erythema, edema, scaling,dryness, burning, stinging & itching