LentigoNCT01136629
Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion
An observational study of Lentigo and Melasma, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- How many people
- 160 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2008to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital, Singapore
Singapore, Singapore, 119074
Thiam Chye Lim, MD, 65-67722022, surlimtc@nus.edu.sg
Eileen Hing, 65-67722276, surhch@nus.edu.sg
About this study
Official title: 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.
Read the 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.
- Keywords
- Hyper-pigmented spots, Lentigines, Mealsma, RNA extraction, Isolation of Keratinocytes, Isolation of Melanocytes
- Medical subject headings
- Lentigo, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 2008
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LentigoStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Thiam Chye Lim, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136629
- Sponsor's protocol ID
- NUHS/SUR-PRAS/2010/4
- Other IDs
- D / 08 / 175
- Status last verified
- Jan 2014
- First submitted
- 2 Jun 2010
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion.
- ClinicalTrials.gov ID
- NCT01136629
- Acronym / sponsor ID
- NUHS/SUR-PRAS/2010/4
- Keywords
- Hyper-pigmented spots, Lentigines, Mealsma, RNA extraction, Isolation of Keratinocytes, Isolation of Melanocytes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnant and lactating women
- Children under the age of 20
- Neoplasm (past or present) in excised area
- Patients with communicable disease
- Immuno-compromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thiam Chye Lim, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lentigo and Melasma, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thiam Chye Lim, MD (65-67722022, surlimtc@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization and classification of lentigines and melasma (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.