To the effect of IDC products on dark spots on face and neck.
- Conditions
- hyper pigmentation/dark spots of the face and neck.
- Registration Number
- CTRI/2012/02/002434
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- 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. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
‘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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method improvement in spots darkenss MASI scoring 12 weeks Physicians Global Assessment Grade for improvement in complexion / dark spots on the face and neck 12 weeks Patients Global Assessment Grade for improvement in complexion / dark spots on the face and neck 12 weeks Quality of life Questionnaire 12 weeks Patient Satisfaction Questionnaire 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Cutis Clinic
🇮🇳Bangalore, KARNATAKA, India
Dr. Jerajani Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Kharkars Skin Clinic
🇮🇳(Suburban), MAHARASHTRA, India
Dr. Sarangis clinic
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Shanaz Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Tahilianis Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Radiance Skin Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Shree Krishna Polyclinic
🇮🇳Mumbai, MAHARASHTRA, India
Skin & Laser Clinic
🇮🇳Hyderabad, ANDHRA PRADESH, India
Skin Secrets
🇮🇳Mumbai, MAHARASHTRA, India
Cutis Clinic🇮🇳Bangalore, KARNATAKA, IndiaDr B S ChandrashekharPrincipal investigator9740091155cutisclinic@gmail.com