Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion

Melasma Clinical Trial

Official title:

Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01136629
• Other study ID #: NUHS/SUR-PRAS/2010/4
• Secondary ID: D / 08 / 175
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2010
• Last updated: January 26, 2014
• Start date: June 2008
• Est. completion date: May 2015

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: Thiam Chye Lim, MD
• Phone: 65-67722022
• Email: surlimtc[@]nus.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lentigo
• Melasma

Locations

Country	Name	City	State
Singapore	National University Hospital, Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No