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1 Clinical Trial Details (PDF Generation Date :- Sat, 30 Mar :19:30 GMT) CTRI Number Last Modified On 26/12/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/03/ [Registered on: 20/03/2012] - Trial Registered Prospectively No Interventional Other (Specify) [Cosmoceutical] Randomized, Parallel Group, Active Controlled Trial Efficacy evaluation of cosmetic formulations in conferring dark spot reduction, wrinkle reduction and enhanced skin even tone in healthy human volunteers Efficacy evaluation of cosmetic formulations in conferring dark spot reduction, wrinkle reduction and enhanced skin even tone in healthy human volunteers Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Designation Affiliation Details of Principal Investigator Principal Investigator MS Clinial Research Pvt Ltd Address MS Clinical Research Pvt Ltd Mezzanine Floor, Classic Court 9/1 Richmond Road, Bangalore Bangalore Phone Fax Designation Affiliation mukta.sachdev@mscr.in Details Contact Person (Scientific Query) Principal Investigator MS Clinial Research Pvt Ltd Address MS Clinical Research Pvt Ltd Mezzanine Floor, Classic Court 9/1 Richmond Road, Bangalore Details Contact Person (Public Query) Phone Fax Designation Affiliation mukta.sachdev@mscr.in Details Contact Person (Public Query) Principal Investigator MS Clinial Research Pvt Ltd Address MS Clinical Research Pvt Ltd Mezzanine Floor, Classic Court 9/1 Richmond Road, Bangalore page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Phone Fax > mukta.sachdev@mscr.in Source of Monetary or Material Support Primary Sponsor Details ITC RD Centre Address Peenya Industrial Area,I Phase, Peenya,Bangalore , Karnataka, Type of Sponsor List of Countries of Principal Investigator Other [FMCG Company] Address of Site Site Address Phone/Fax/ MS Clinical Research Pvt Ltd MS Clinical Research Pvt Ltd Mezzanine Floor, Classic Court,9/1 Richmond Road, Bangalore , Bangalore mukta.sachdev@mscr.i n of Committee Approval Status Date of Approval Is Independent Ethics Committee? IEC Aditya, Ahmedabad Approved 07/03/2012 Yes Status Not Applicable Health Type Healthy Human Volunteers Date No Date Specified Condition healthy subjects with at least 2 and preferably more than 4-5 prominent wrinkles on crow feet area,has hyperpigmentary spots on face. Type Details Intervention CSWRS A Applied twice daily on face, 6 week sper volunteer Intervention CSWRS B Applied twice daily on face, 6 weeks per volunteer Intervention CWRS- C Applied twice daily on face, 6 weeks per volunteer Intervention CWRS - D Applied twice daily on face, 6 weeks per volunteer Comparator Agent Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Subject willing to give a written informed consent and come for regular observations Subject is a healthy adult, male or female, in the age range of 18 page 2 / 7

3 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Other Other Participant and Investigator Blinded and 55 years Subject has at least 2 and preferably more than 4-5 prominent wrinkles on crow feet area Subject has at least 2 and preferably more than 4-5 hyperpigmentary spots on face that are freckles, age spots, post inflammatory hyperpigmentation spots like post acne marks, Sebhorreic dermatitis, etc on face Subject has not participated in a similar clinical investigation in the past three months. Subject who is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at parlour during the entire study course. In case of having used fairness product in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face. Male subjects who are willing to maintain their facial skin condition as shaved at baseline and during the entire study course. Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test. Female subjects of reproductive age group should undergo UPT at time of screening visit. Exclusion Criteria Subject with a known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or their ingredients including fragrance. Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study. Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results. Subject with excessive facial hair or scars, which could interfere with evaluation. Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement. Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course. Subjects viewed by the investigator as not being able to complete the study Primary Outcome Outcome Timepoints study the efficacy of investigational products in reducing hyper pigmentation spots in terms of intensity, size and number in comparison to baseline, comparison to each other. To study the efficacy of investigational products in reducing wrinkle in comparison to baseline. To study the efficacy of investigational products Week 1 to Week 6 page 3 / 7

4 in reducing wrinkle in comparison to each other. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=160 Sample Size from =160 20/03/2012 No Date Specified Years=0 Months=2 Days=0 Not Applicable Completed Efficacy evaluation of cosmetic formulations in conferring dark spot reduction, wrinkle reduction and enhanced skin even tone in healthy human volunteers Primary objectives: To study the efficacy of investigational products in reducing hyper pigmentation spots in terms of intensity, size and number in comparison to baseline. To study the efficacy of investigational products in reducing hyper pigmentation spots in terms of intensity, size and number in comparison to each other. To study the efficacy of investigational products in reducing wrinkle in comparison to baseline. To study the efficacy of investigational products in reducing wrinkle in comparison to each other. Secondary objectives: To study the efficacy of investigational products in enhancing evenness of skin tone in comparison to baseline. To study the efficacy of investigational products in enhancing evenness of skin tone in comparison to each other. Double blind, parallel design, comparative, controlled, single centre trial. Total 160 healthy human male and female adult subjects subjects in each of the 4 treatment groups. page 4 / 7

5 Instrumental measurements- Visioscan (SEsw, SEsm), Photography/ Image Pro Dermatologist s visual assessment of varied skin attributes Subject s self assessment of varied skin attributes CSWRS A CSWRS B CSWRS C CSWRS D Totally 160 healthy human adult, male and female volunteers, in the age group of yrs, representing varied skin types. 80 subjects having at least 2 and preferably more than 4 post inflammatory hyperpigmentation spots on face. 80 subjects having at least 2 and preferably more than 4 prominent wrinkles on crow s feet area. General physical examination, medical history of subjects and skin sensitivity test Subject willing to give a written informed consent and come for regular observations Subject is a healthy adult, male or female, in the age range of 18 and 55 years Subject has at least 2 and preferably more than 4-5 prominent wrinkles on crow feet area Subject has at least 2 and preferably more than 4-5 hyperpigmentary spots on face that are freckles, age spots, post inflammatory hyperpigmentation spots like post acne marks, Sebhorreic dermatitis, etc on face Subject has not participated in a similar clinical investigation in the past three months. Subject who is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at parlour during the entire study course. In case of having used fairness product in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face. Male subjects who are willing to maintain their facial skin condition as shaved at baseline and during the entire study course. Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test. Female subjects of reproductive age group should undergo UPT at time of screening visit. Subject with a known history or present condition of allergic response to any page 5 / 7

6 cosmetic/pharmaceutical products, toiletries or their ingredients including fragrance. Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study. Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results. Subject with excessive facial hair or scars, which could interfere with evaluation. Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement. Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course. Subjects viewed by the investigator as not being able to complete the study. 6 weeks from evaluation commencement of each subject General Physical and Dermatologist s examination will be done at the screening, during the evaluation and post evaluation. Subject s discretion: A subject may voluntarily withdraw from the study at any time, citing the reason to the investigator without loss of any benefit that he or she may be otherwise entitled to. Investigators will share all information regarding the study that may possibly affect the subject s willingness to participate in the trial. Investigator s discretion: Investigator may discontinue a subject s participation from the study in case of the following events- Non-compliance to the study restrictions and protocol Possible threat to subject s safety, health or study results Development of hypersensitivity to test product or any other intolerable adverse event due to participation in the study as determined by the investigator or subject Development of disease or illness by the subject rendering them unsuitable to participate in the study Discovery that the subject entered the study in violation of the protocol or occurrence of a significant protocol violation during the study Misbehavior that could affect other subjects or investigators Mis-conduct that could affect the smooth operation of the study page 6 / 7

7 Powered by TCPDF ( Treatment Products CSWRS A CSWRS B CSWRS C CSWRS D page 7 / 7