Association of Leucocyte Telomere Length With DPAS Score in Skin Aging

July 9, 2024 updated by: Dr.dr.Irma Bernadette, SpKK (K)

Association of Leucocyte Telomere Length With Clinical Examination and Dermoscopic Photoaging Scale (DPAS) Score in Skin Aging: a Pilot Study

The goal is to know the profile of photoaging based on clinical examination, Dermoscopic Photoaging Scale and leucocyte telomere length

The main questions of Research are:

  • what is the profile of photoaging based on clinical examination results in skin aging
  • what is the profile of photoaging based on DPAS Score in skin aging
  • what is the profile of leucocyte telomere length in skin aging

Participants are female and male with the age of 29-31 years old and 59-61 years old. They will be examined by dermatovenereologist and will be photographed in 5 positions, they will get dermocopy on forehead, right cheek , left cheek, and chin, and their blood will be drawn about 10 mL in order to get the profile of leucocyte telomere length

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Skin aging is a process of deterioration in the physiological structure and function of the skin that significantly increases in the 4th and 5th decades of life. Skin aging is a combination of physiological and pathological aging. Physiological change cannot be avoided and mandatory for everyone, pathological aging ir extrinsic aging is an abnormal skin condition caused by cigarettes, pollution and ultraviolet (UV). In general, the clinical characteristics of skin aging consist of pigmentation changes, hydration disorders, the appearance of wrinkles and skin tumors. The photoaging assessment was first proposed in 1996 by Dr. Richard Glogau, The Glogau scale assesses photoaging based on clinical assessment grouped into 4 categories, namely types I, II, III, and IV,where each type is graded by the severity of wrinkles, namely from mild, moderate, advanced, and severe. Isik et al. developed an instrument for quantitative skin aging assessment using dermoscopy. This examination is non-invasive and is expected to provide a more objective assessment. There are four facial regions assessed in the DPAS score calculation: forehead, right cheek, left cheek, and chin. The sum of the scores of the four regions is assessed based on 11 parameters, with a maximum final score of 44. Telomeres are repetitive DNA-Protein complexes located at the ends of chromosomes of eukarotic cells, and their function is to maintain chromosome stability during cell division, by protecting chromosomes from degradation and fusion. Many factors affect telomere length, such as body mass index, hormonal therapy, antioxidant intake, chronic diseases, and gender. Research by son et al. found that telomere length shortening was validated to increase the odds of skin aging (OR=0.96, 95% CI: 0.9332-0.99566, P= 0.03) Telomeres are closely linked to cellular aging, especially in dermal cells and telomere shortening in skin fibroblasts may lead to epidermal aging and barrier function defectcs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female and Male (age 29-31 years old and 59-61 years old
  • signs of aging

Exclusion Criteria:

  • pregnant or breastfeeding
  • have disease or genetic problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: lifestyle counseling
patient will be asked about the mean of sun exposure per week
Genetic: Leucocyte Telomere Length from blood draw
blood draw, PCR method to see leucocyte telomere length
Experimental: Clinical examination
patients's face were assessed by the doctor by using Glogau scale and the doctor will perform dermoscopic tes to assess dermoscopic photoaging scale (DPAS) score to obtain the score of skin aging
Genetic: Leucocyte Telomere Length from blood draw
blood draw, PCR method to see leucocyte telomere length

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
profile of leucocyte telomere length
Time Frame: 1 year
profile of leucocyte telomere length in skin aging
1 year
Profile of skin examination from Glogau scale
Time Frame: 1 year
Glogau type 1 (mild) is without wrinkles (Age of 28-35 years), type II (moderate) is wrinkles in motion (age of 35-50 years), III (advanced) with wrinkles at rest (age of 50-65 years), type IV (severe) is wrinkles all over the face (age of 60-75)
1 year
profile of skin examination with dermoscopic photoaging scale (DPAS)
Time Frame: 1 year

skin aging is assessed from dermoscopic photoaging scale on dermoscopic images, looking at pigmentary changes, vascular changes, telangiectasis, wrinkles, actinic keratoses, and blackheads. There are four facial regions assessed in the DPAS score calculation, namely the forehead, right cheek, left cheek, and chin. The sum of the scores of the four regions is assessed based on 11 parameters, with a maximum final score of 44.

The greater the score, the higher marks of skin aging
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr.dr.Irma Bernadette, SpKK (K)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indonesian Medical Education and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • tes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

provide positive impact for Cipto Mangunkusumo National Hospital and worldwide

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Leucocyte Telomere Length from blood draw

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings