Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion
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Purpose
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.
| Condition |
|---|
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Lentigo Melasma |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion. |
- Characterization and classification of lentigines and melasma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
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Detailed Description:
Aims -
- 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.
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)
- 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)
Sample processing
- RNA extraction
- Histology
- Isolation of Keratinocytes, and Melanocytes.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Solar Lentigines and/or Melasma on facial, or neck areas
- Ethnic background: Chinese, Malay, Indian, Caucasian
- Age 21 - 80 years old
- Ability to provide informed consent
Exclusion Criteria:
- Pregnant and lactating women
- Children under the age of 20
- Neoplasm (past or present) in excised area
- Patients with communicable disease
- Immuno-compromised patients
- Current treatment with an investigational drug
Contacts and Locations| Contact: Thiam Chye Lim, MD | 65-67722022 | surlimtc@nus.edu.sg |
| Contact: Eileen Hing | 65-67722276 | surhch@nus.edu.sg |
| Singapore | |
| National University Hospital, Singapore | Recruiting |
| Singapore, Singapore, 119074 | |
| Contact: Thiam Chye Lim, MD 65-67722022 surlimtc@nus.edu.sg | |
| Contact: Eileen Hing 65-67722276 surhch@nus.edu.sg | |
| Principal Investigator: Thiam Chye Lim, MD | |
| Principal Investigator: | Thiam Chye Lim, MD | National University Hospital, Singapore |
More Information
No publications provided
| Responsible Party: | LIM THIAM CHYE / Professor, National University Hospital, Singapore |
| ClinicalTrials.gov Identifier: | NCT01136629 History of Changes |
| Other Study ID Numbers: | NUHS/SUR-PRAS/2010/4, D / 08 / 175 |
| Study First Received: | June 2, 2010 |
| Last Updated: | June 2, 2010 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by National University Hospital, Singapore:
|
Hyper-pigmented spots Lentigines Mealsma |
RNA extraction Isolation of Keratinocytes Isolation of Melanocytes |
Additional relevant MeSH terms:
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Lentigo Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013