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.

Study Overview

• Status: Unknown
• Conditions: Melasma; Lentigo

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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital, Singapore
    • Contact: Thiam Chye Lim, MD; Phone Number: 65-67722022; Email: surlimtc@nus.edu.sg
    • Contact: Eileen Hing; Phone Number: 65-67722276; Email: surhch@nus.edu.sg
    • Principal Investigator: Thiam Chye Lim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ANTICIPATED): May 1, 2015
• Study Completion (ANTICIPATED): May 1, 2015

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (ESTIMATE): June 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2014
• Last Update Submitted That Met QC Criteria: January 26, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Lentigines; Hyper-pigmented spots; Mealsma; RNA extraction; Isolation of Keratinocytes; Isolation of Melanocytes
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Melanosis; Lentigo; Hyperpigmentation
• Other Study ID Numbers: NUHS/SUR-PRAS/2010/4; D / 08 / 175 (REGISTRY: DSRB - D / 08 / 175)