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Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National University Hospital, Singapore
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01136629
First received: June 2, 2010
Last updated: January 26, 2014
Last verified: January 2014

June 2, 2010
January 26, 2014
June 2008
May 2015   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01136629 on ClinicalTrials.gov Archive Site
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Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion
Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion.

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 -

  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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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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.

  • Lentigo
  • Melasma
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
21 Years to 80 Years
No
Contact: Thiam Chye Lim, MD 65-67722022 surlimtc@nus.edu.sg
Contact: Eileen Hing 65-67722276 surhch@nus.edu.sg
Singapore
 
NCT01136629
NUHS/SUR-PRAS/2010/4, D / 08 / 175
Yes
LIM THIAM CHYE / Professor, National University Hospital, Singapore
National University Hospital, Singapore
Not Provided
Principal Investigator: Thiam Chye Lim, MD National University Hospital, Singapore
National University Hospital, Singapore
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP