Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 2, 2010 | ||||||||
| Last Updated Date | June 2, 2010 | ||||||||
| Start Date ICMJE | June 2008 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion | ||||||||
| Official Title ICMJE | Clinical, Histological and Biochemical Characterization of Hyperpigmented Lesion. | ||||||||
| 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. |
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| Detailed Description | Aims -
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)
Morphological assessment (before surgery)
Spectrophotometer will be used to measure the optical properties of spots and control areas (without the spot) Sample processing
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 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. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 160 | ||||||||
| Estimated Completion Date | May 2012 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Singapore | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01136629 | ||||||||
| Other Study ID Numbers ICMJE | NUHS/SUR-PRAS/2010/4, D / 08 / 175 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | LIM THIAM CHYE / Professor, National University Hospital, Singapore | ||||||||
| Study Sponsor ICMJE | National University Hospital, Singapore | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National University Hospital, Singapore | ||||||||
| Verification Date | June 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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