An observational study in Lentigo and Melasma, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-01-28.
Sponsored by National University Hospital, Singapore · Observational
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.
Aims -
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.
Methodology -
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)
Morphological assessment (before surgery)
Spectrophotometer will be used to measure the optical properties of spots and control areas (without the spot)
Sample processing
28 studies on the registry are indexed under Lentigo; 2 are open to participants now.
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Subjects age 21 to 80 year old, who have elected to undergo a plastic surgery will be enrolled. Patients will be from Chinese, Malay, Indian or Caucasian ancestry. Patients will be female or male with hyper-pigmented spots.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 3 years
The record gives a start of Jun 2008, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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