NCT01136629

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

6.9 years

First QC Date

June 2, 2010

Last Update Submit

January 26, 2014

Conditions

Keywords

Hyper-pigmented spotsLentiginesMealsmaRNA extractionIsolation of KeratinocytesIsolation of Melanocytes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Singapore

Singapore, Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

LentigoMelanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thiam Chye Lim, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thiam Chye Lim, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

June 1, 2008

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations