Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion
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|ClinicalTrials.gov Identifier: NCT01136629|
Recruitment Status : Unknown
Verified January 2014 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : June 3, 2010
Last Update Posted : January 28, 2014
The developments of solar lentigine and melasma are due to mutations in keratinocytes that drive the production and transfer of pigment from melanocytes to keratinocytes.
|Condition or disease|
- Characterize and classify lentigines and mealsma from a clinical and physiological point of view. This will help us to better understand the cellular processes leading to the development of lentigines (also referred to as Senile or Solar Lentigo).
- Proper characterization and classification of lentigines and melasma would facilitate the development of models to study and find solutions to treat these lesions.
Hypothesis - The developments of solar lentigine and melasma are due to mutations in keratinocytes that drive the production and transfer of pigment from melanocytes to keratinocytes.
Patients, 21 - 80 year old, who have elected to undergo a plastic surgery will be enrolled. Some patient information (i.e. age, sex, race, family history, life-style related to sun-exposure) will be collected.
After surgery, hyper-pigmented spots will be excised and stored in individual containers for subsequent experimental procedures.
Before surgery, the area containing the hyper-pigmented spots will be photographed using a high resolution digital camera and assessed using optical probes (Spectrophotometer to measure skin chromophores, mexameter to measure the melanin and erythema indexes and a diffuse reflectance spectrometer to measure hemoglobin, deoxyhemoglobin and melanin).
After surgery, excised skin samples will be processed for histological assessments, others for gene or protein expression analysis, and yet another group will be used to isolate keratinocyte and melanocyte to further study their behavior and response to stimuli in primary cultures.
Clinical assessment of Hyperpigmented lesions:
Lentigo Morphological assessment (before surgery)
- Macules vary in color from yellow, light-brown to black, depending on under-lying skin type
- Size varies from 1mm to greater than 1 cm
- Appear on sun-exposed areas (face, neck, etc)
Morphological assessment (before surgery)
- Irregular light to dark brown to gray brown macules or patches on sun-exposed areas
- When examine with Wood's lamp, melasma can be classified into 3 types, epidermal, dermal, or mixed, based on intensity of pigments, in which epidermal melasma has darker color than derma melasma. Mixed melasma has a mixture of both dark and light pigmentations
- Melanocytes in melasma lesion have an increase in the number of mitochondria, golgi apparatus, rough ER, and ribosomes
Spectrophotometer will be used to measure the optical properties of spots and control areas (without the spot)
- RNA extraction
- Isolation of Keratinocytes, and Melanocytes.
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion.|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2015|
Subjects with hyper-pigmented spots
Subjects age 21 to 80 year old, who have elected to undergo a plastic surgery will be enrolled. Subjects will be from Chinese, Malay, Indian or Caucasian ancestry. Subjects will be female or male with a hyper-pigmented spots.
- Characterization and classification of lentigines and melasma [ Time Frame: 3 years ]
Characterize and classify lentigines and mealsma from a clinical and physiological point of view. This will better understand the cellular processes leading to the development of lentigines (also referred to as Senile or Solar Lentigo).
Proper characterization and classification of lentigines and melasma would facilitate the development of models to study and find solutions to treat these lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136629
|Contact: Thiam Chye Lim, MDfirstname.lastname@example.org|
|Contact: Eileen Hingemail@example.com|
|National University Hospital, Singapore||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Thiam Chye Lim, MD 65-67722022 firstname.lastname@example.org|
|Contact: Eileen Hing 65-67722276 email@example.com|
|Principal Investigator: Thiam Chye Lim, MD|
|Principal Investigator:||Thiam Chye Lim, MD||National University Hospital, Singapore|