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CTRI Number  CTRI/2012/02/002420 [Registered on: 14/02/2012] Trial Registered Retrospectively
Last Modified On: 29/08/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Other 
Public Title of Study   Study of effectiveness of a day cream product in combination with a night cream in reducing dark spots in asian adult females over a period of 3 months 
Scientific Title of Study
Modification(s)  		 Clinical evaluation of the in vivo efficacy of a day cream product at reducing various forms of hyper pigmentation on Asian skin over 3 months in conjunction with a basic night cream, applied under normal conditions of use by adult subjects. 
Trial Acronym  Not Applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
11DE019, Version 01 of 16 Jan 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sah Gaurang Krishna 
Designation  Prinicipal Investigator 
Affiliation  CIDP Biotech India Pvt. Ltd. 
Address  CIDP Biotech India Pvt. Ltd. N-110, 3rd Floor, Max Medcentre, Panchsheel Park, New Delhi

South
DELHI
110017
India 
Phone  011-40793385  
Fax  011-40793386  
Email  gaurangkrishna3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Miglani 
Designation  COO & Scientific Director 
Affiliation  CIDP Biotech India Pvt. Ltd. 
Address  CIDP Biotech India Pvt. Ltd. N-110, 3rd Floor, Max Medcentre, Panchsheel Park, New Delhi

South
DELHI
110017
India 
Phone  011-40793385  
Fax  011-40793386  
Email  smiglani@cidp-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Aalok Makker 
Designation  Study manager 
Affiliation  CIDP Biotech India Pvt. Ltd. 
Address  CIDP Biotech India Pvt. Ltd. N-110, 3rd Floor, Max Medcentre, Panchsheel Park, New Delhi

South
DELHI
110017
India 
Phone  011-40793385  
Fax  011-40793386  
Email  amakker@cidp-cro.com  
 
Source of Monetary or Material Support  
Oriflame Research and Development Ltd. Skin care and Claims Support Bray Business Park Kilruddery Bray Co.Wicklow Ireland 
 
Primary Sponsor  
Name  Oriflame Research and Development Ltd 
Address  Skin care and Claims Support Bray Business Park Kilruddery Bray Co.Wicklow Ireland 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
CIDP Biotech India Pvt Ltd  3rd Floor, Max Medcentre, N-110, Panchsheel Park, New Delhi-110017 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sah Gaurang Krishna  CIDP Biotech India Pvt. Ltd.  CIDP Biotech India Pvt. Ltd. Dermatology division, 3rd Floor, Max Medcentre, N-110, Panchsheel Park, New Delhi-110017
South
DELHI 		 01140793385
01140793386
gaurangkrishna3@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALERT EC (IEC)- Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Asian females with melasma, Ageing Spots, Post- acne Inflammatory Hyperpigmentation  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  24883 Day Cream SPF40 with Night cream A (24191)   Day Cream:0.5g (or a pea size amount) of Day Cream to be applied to each half face left and right (cheek, forehead, nose, chin and jaw). Daily application for 84 days. Night Cream: 0.5 g (or a pea size amount) of Night cream A (24191) to be applied on one hemi-face (according to the randomization list). Daily application for 84 days. 
Comparator Agent  24883 Day Cream SPF40 with Night Cream B (24544)  Day Cream:0.5g (or a pea size amount) of Day Cream to be applied to each half face left and right (cheek, forehead, nose, chin and jaw). Daily application for 84 days. Night Cream: 0.5 g (or a pea size amount) of Night cream B (24544) to be applied on one hemi-face (according to the randomization list). Daily application for 84 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  • Healthy Indian subjects,
• Sex: female,
• Age: 18 – 65 years old,
• Subject having at least one of the following on both the left and right profiles of the face
- moderate melasma
- a dark spot severity score of 1-3 according to the Spot Contrast scale (Skin Ageing Atlas, Asian type by Bazin and Doublet)
- moderate Post Acne hyperpigmentation
• Fitzpatrick skin types III – V,
• Subject not using skin lightening facial product at least 12 weeks prior to trial,
• Subject having given freely and expressly her informed consent, cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol can be expected,
• Subject who is able to read and understand documents transmitted (consent and information sheet),
• Subject accepting not to apply cosmetic products other than those she usually applies and at their usual frequency of application,
• Subject having access to health services.
 
 
ExclusionCriteria 
Details  • Subject who is unwilling or unable to give informed consent or to otherwise comply with protocol requirements,
• Subject who is pregnant or nursing or who is planning a pregnancy during the study,
• Subject exhibiting active acne,
• Subject who is acne prone,
• Subject having started, changed or interrupted any hormonal treatment (contraceptive, HRT, thyroid) during the past 3 months or intending to change during the study,
• Subject having taken within 12 weeks prior to the study any systemic antibiotics, steroids, or any oral anti acne medications such as retinoids within 6 months prior to the study,
• Current use of immunosuppressive drugs and/or an organ transplant,
• Current use of topical or systemic anti-inflammatory drugs for a defined medical condition, e.g. aspirin, ibuprofen, corticosteroids,
• Currently receiving allergy injections, final injection within the last week, or expecting to begin injections during the course of the study,
• Insulin-dependent diabetes,
• Immune deficiency or autoimmune disease,
• Skin disorders affecting the study area which, in the investigator’s judgment, would interfere with the grading / assessment of the skin response (e.g. acne, psoriasis, scars, hyperhidrosis, etc, …),
• Subjects with any skin disorder that could compromise evaluation of skin reactions,
• Vaccination during the three weeks preceding the study or intention to be vaccinated during the course of the study,
• Current participation in another clinical study of any kind,
• Subject who cannot be contacted in case of emergency,
• Febrile disease in the three days preceding the study,
• Personnel of the investigating laboratory
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Clinical scoring by the dermatologist investigator on the evolution of the different types of hyperpigmentations, according to defined scales
2. Image analysis of the images captured for the front, left and right profiles of subjects face with VISIA-CR, under standard-2 and cross-polarized light.
3. Subjective evaluation of the anti-hyperpigmentation and lightening effects of the
investigational products and of its cosmetic acceptability by the subjects 		 Day 0, Day 28, Day 56 and Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Report of intolerance sensations.  Day 0, Day 28, Day 56 and Day 84 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/02/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
This study intends to evaluate the efficacy of the care product “24883 Day Cream SPF40 Formula No. Alt 18”, in association with two basic night creams and assess its cosmetic qualities, after application for 84 consecutive days under the normal conditions of use on female Indian adult subjects. The primary objectives is to determine the anti-hyperpigmentation and lightening effect of the care product “24883 Day Cream SPF40 Formula No. Alt 18” when used in combination with Night Cream A compared to when used in combination with Night Cream B, on female Indian adult subjects in three groups of melasma, ageing spots and post acne hyperpigmentation. The secondary objective is to report intolerance sensations.  The product application will be done for consecutive 84 days. The study duration is 3 months. The anti-hyperpigmentation and lightening effects will be evaluated by (1) clinical scoring of the severity of different hyperpigmentations on left and right cheeks by the dermatologist investigator (2) image analysis for the front, left and right profiles of images of subjects face captured using VISA-CR, (3) subjective evaluation of the effects of the products and cosmetic acceptability by the subjects. The study is comparative, open-labeled and randomized, with respect to the night creams. Night creams A and B will be applied on each hemi- face.  0.5 g (pea size amount) of each of the product (day cream in the day and night cream at night) will be applied to the hemi-face. Day cream would be applied to the entire face (0.5 g left and 0.5 g right). Each of the subject will apply both night cream A and B on either side of the face according to the randomization sequence. 


 
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