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CTRI Number  CTRI/2012/02/002434 [Registered on: 21/02/2012] Trial Registered Retrospectively
Last Modified On: 06/09/2012
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To the effect of IDC products on dark spots on face and neck. 
Scientific Title of Study   To assess the Efficacy, Quality of life and Safety of Image Blanc as a Complexion Lightener / Spot Lightener for the face and neck. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GPL/Image Blanc /0711/v 01   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shehnaz Arsiwala 
Designation  Principal Investigator 
Affiliation  Prince ali khan hospital 
Address  332, Sir J. J. Road, Honda Mansion, Byculla, Mumbai-8

Mumbai
MAHARASHTRA
400008
India 
Phone  9821214856  
Fax    
Email  drshenaz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amanjit Ahluwalia 
Designation  Sr. manager 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd, Corporate enclave, 3rd floor, B D Sawant marg, chakala, andheri (E), mumbai 400099

Mumbai
MAHARASHTRA
400099
India 
Phone    
Fax    
Email  amanjita@glenmarkpharma.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amanjit Ahluwalia 
Designation  Sr. manager 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd, Corporate enclave, 3rd floor, B D Sawant marg, chakala, andheri (E), mumbai 400099

Mumbai
MAHARASHTRA
400099
India 
Phone    
Fax    
Email  amanjita@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd, Corporate enclave, 3rd floor, B D Sawant marg, chakala, andheri (E), mumbai 400099 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  Corporate enclave, 3rd floor, B D Sawant marg, chakala, andheri (E), mumbai 400099 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B S Chandrashekhar  Cutis Clinic  20, 3rd cross, Opp. Chandra Layont, New Police Station, Chandra layout, Vijaynagar, banglore 560040
Bangalore
KARNATAKA 
9740091155

cutisclinic@gmail.com 
DR Hema Jerajani  Dr. Jerajani Clinic  Shukanje, 109/ArunaagarII, Off J P Road, Versova Andheri (W), Mumbai 400061
Mumbai
MAHARASHTRA 
9820031483

jerajani@rediffmail.com 
Dr R D Kharkar  Dr. Kharkars Skin Clinic  55, 5th Floor, Dattani Chambers, Oppm Shantinath Shopping Centre, S.V.Road., Malad-w, Mumbai-400064.
Mumbai (Suburban)
MAHARASHTRA 
9821420956

drrdkharkar@yahoo.com 
Dr Kalpana sarangi   Dr. Sarangis clinic  304, Mohinis corner, Annapurna CHSL, New link road, oshiwara, Andheri (W), mumbai 400102
Mumbai
MAHARASHTRA 
9820188903

drkalpanas@hotmail.com 
Dr Shanaz Arsiwala  Dr. Shanaz Clinic  332, Sir J. J. Road, Honda Mansion, Byculla, Mumbai-8
Mumbai
MAHARASHTRA 
9821214856

drshenaz@gmail.com 
Dr Sushil Tahiliani  Dr. Tahilianis Clinic  1st floor, Arun Bazar, S V road, malad (W), Mumbai 400064
Mumbai
MAHARASHTRA 
9820492415

dr_sushil@rediffmail.com 
Dr Falguni Shah  Radiance Skin Clinic  Shop No 104, Juhu Sagar Building, Juhu Versova, Link Road, Near Zaf Fitness Club, Juhu, Mumbai - 400053
Mumbai
MAHARASHTRA 
032974697

radianceclinic04@gmail.com 
Dr Preeti Sawardekar  Shree Krishna Polyclinic  Krishna Bldg, Jayvant Palakar Marg, Worli, Mumbai-400025
Mumbai
MAHARASHTRA 
9820450568

drpreeti25@rediffmail.com 
Dr Sanjiv Aurangabadkar  Skin & Laser Clinic  1st floor, Brij Tarang, Greenlands, Begumpeth, Hyderabad- 500016
Hyderabad
ANDHRA PRADESH 
9618090000

sanjeev.aurangabadkar@gmail.com 
Dr Malavika Kohli  Skin Secrets   306, Doctor house, 14, Pedder road Mumbai 400 026
Mumbai
MAHARASHTRA 
23511997

malavika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
league Health independent ethics committe (Mumbai)  Approved 
league Health independent ethics committe (Mumbai)- investigators list  Approved 
league Health independent ethics committe (Mumbai)- investigators list 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  hyper pigmentation/dark spots of the face and neck.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IDC Image blanc products IMAGE BLANC- complexion lightener- corrective anti aging serum IMAGE BLANC- spot lightener – anti spots concentrate for targeted application   Appropriate amount to be applied externally on targeted areas or face and neck. Twice daily application for 12 weeks. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects with hyper pigmentation/dark spots of the face and neck.
Age group: 30 years and above
Willing to restrain from prolonged exposure to the sun for the length of the study
Available for the entire duration of the study
 
 
ExclusionCriteria 
Details  Hypersensitivity to any ingredients
Pregnant and lactating women.
Subjects who are already applying anti-aging, skin lightening or AHA (Alpha hydroxy acids) based or retinol based cosmetics or have applied any of these in the last 3 months.
Subjects with dermatological disorder of face that may interfere with study evaluation.
Subjects who have undergone any surgical treatment of the face.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
improvement in spots darkenss MASI scoring
Physicians Global Assessment Grade for improvement in complexion / dark spots on the face and neck
Patients Global Assessment Grade for improvement in complexion / dark spots on the face and neck
Quality of life Questionnaire
Patient Satisfaction Questionnaire
 
12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   16/08/2011 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

‘Dark spots’ on the skin, also called hyperpigmentation, is a common skin problem especially beginning in middle age. There are a variety of conditions and agents that can cause dark spots to develop. UV light is a major cause of dark spots and the commonest types are Lentigines and Melasma.

‘Lentigines’ are flat brown-black spots that usually occur in ‘sun-exposed’ areas, which occur commonly on face and backs of hands. The lesions tend to increase in number with ‘age’, making them common among the middle age and older population. They vary in size from 0.2 to 2 cm and usually have discrete borders, dark in color and have an irregular shape. These lesions are caused by a marked increase in the number of pigment cells located in the superficial layers of the skin.

‘Melasma’, or chloasma or the ‘mask of pregnancy’ as it is also called, are tan or brown spots which discolor the skin. Generally the symptoms include dark patches and spots on the cheeks, nose, forehead or upperlip. The exact cause of melasma remains elusive, but the two most important factors implicated in its etiopathogenesis are sunlight and genetic predisposition.

ü  Exacerbations of melasma are inevitably seen after a period of sun exposure.

 

ü  Genetic factors are also involved as suggested by familial occurrence and the higher prevalence of the disease amongst Asians.

 

ü  Other factors incriminated in the pathogenesis of melasma include pregnancy, oral contraceptives, estrogen-progesterone therapies, thyroid dysfunction, cosmetics, and phototoxic and antiseizure drugs.

 

IDC stands for ‘Integral Dermo Correction’. It is an innovating approach offering the only anti-age products that target all the main causes of skin aging with the highest concentrations of cosmetic active ingredients. IDC targets all the mechanisms responsible for skin aging. IDC is a combination of cosmetic active ingredients selected for their effectiveness and safety.

Image Blanc (Complexion Lightener) integral serum to be applied morning and night to the face and neck; (Image Blanc Spot Lightener- Anti-spots concentrate to be applied only on the affected area on the face and neck with dark  spots), after the use of a cleanser (Pearl Gel) for the period of 12 weeks. Additionally, use Sunscreen SPF 25 with moisturizer (Hydra-Seal SPF 25), after approximately 5 minutes of application of IDC anti-wrinkle product.

 

Patients will be recruited based on the inclusion and exclusion criteria. Written ‘Informed consent’ will be obtained from these patients after a thorough explanation of the study. Each patient will receive copy of Informed consent form and Patient information sheet.  Patients will be explained regarding benefits and side effects of the serum as per the available Prescribing Information.

 

At the first visit (Baseline), detailed history and examination of the patients will be performed. A photograph has to be taken at the first visit with the following specifications mentioned below: The photo of face to be captured in a single 4 x 6 inches photograph, taken by a digital camera, with the flash, in a well illuminated room. The distance of the digital camera, without any zoom adjustments, should be approximately 12  inches (+/- 1 inch) from the face, with the eyes closed.

 

During the 2nd visit (End of 6 weeks) and 3rd Visit (End of 12 weeks), the ‘Assessment for Efficacy’ would be done as mentioned below:

Assessment for Efficacy includes the following:

  • *MASI scoring.
  • Physician’s Global Assessment Grade for improvement in complexion / dark spots on the face and neck
  • Patients Global Assessment Grade for improvement in complexion / dark spots on the face and neck
  • Quality of life Questionnaire

Patient Satisfaction Questionnaire

 
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