| 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
|
|
|
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
|
|
|
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 |