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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
Sponsor:
Information provided by:
National University Hospital, Singapore

Study Description
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Brief Summary:

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 or disease
Lentigo Melasma

Detailed Description:

Aims -

  1. 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).
  2. 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)

  1. Macules vary in color from yellow, light-brown to black, depending on under-lying skin type
  2. Size varies from 1mm to greater than 1 cm
  3. Appear on sun-exposed areas (face, neck, etc)

Morphological assessment (before surgery)

  1. Irregular light to dark brown to gray brown macules or patches on sun-exposed areas
  2. 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
  3. 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

  1. RNA extraction
  2. Histology
  3. Isolation of Keratinocytes, and Melanocytes.

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
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Information from the National Library of Medicine

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


Contacts
Contact: Thiam Chye Lim, MD 65-67722022 surlimtc@nus.edu.sg
Contact: Eileen Hing 65-67722276 surhch@nus.edu.sg

Locations
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         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Thiam Chye Lim, MD National University Hospital, Singapore
More Information
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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 ( Registry Identifier: DSRB - D / 08 / 175 )
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014

Keywords provided by National University Hospital, Singapore:
Hyper-pigmented spots
Lentigines
Mealsma
 RNA extraction
Isolation of Keratinocytes
Isolation of Melanocytes

Additional relevant MeSH terms:
Lentigo
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases