NCT06779032

Brief Summary

To determine the relationship between clinical appearance, dermoscopic examination results of photoaging profiles based on clinical examination, DPAS score and leucocyte telomere length, to analyze the relationship between BMI, waist circumference, triglycerides, and cellular senescence biomarker p16 levels with a population experiencing skin aging and having Fitzpatrick III-V skin types. The questions which is aim to be answered are:

  1. 1.What is the photoaging profile based on clinical examination results in skin aging cases?
  2. 2.What is the photoaging profile based on DPAS scores in skin aging cases?
  3. 3.What is the leucocyte telomere length profile in skin aging cases?
  4. 4.What is the relationship between leucocyte telomere length and clinical examination in skin aging cases?
  5. 5.What is the relationship between leucocyte telomere length and DPAS degree in skin aging cases?
  6. 6.What is the profile of cellular senescence p16 biomarker levels in a population that has experienced clinical skin aging with Fitzpatrick III-V skin types?
  7. 7.What is the skin aging profile based on the Glogau and DPAS scales in a population with Fitzpatrick III-V skin types?
  8. 8.Is there a relationship between the results of the cellular senescence p16 biomarker examination and clinical skin aging assessed based on the Glogau and DPAS scales in a population with Fitzpatrick III-V skin types?
  9. 9.Is there a relationship between the results of BMI, waist circumference, and triglyceride examinations with clinical skin aging assessed using the Glogau and DPAS scales with Fitzpatrick III-V skin types?

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
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 22, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

January 16, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 22, 2024

Last Update Submit

January 12, 2025

Conditions

Keywords

skin agingbody mass indextriglycerideswaist circumferencecellular senescenep16

Outcome Measures

Primary Outcomes (6)

  • profile of leucocyte telomere length

    profile of leucocyte telomere length in skin aging

    1 year

  • profile of skin examination with dermoscopic photoaging scale (DPAS)

    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

  • Profile of body mass index

    checking BMI to see if there is correlation so skin aging

    1 year

  • profile of p16

    checking p16 as a cellular senescence to skin aging

    1 year

  • profile of waist circumference

    Waist circumferemce will be checked, to see if there is correlation with skin aging

    1 year

  • profile triglycerides

    triglycerides will be checked, to see if there is correlation with skin aging

    1 year

Study Arms (2)

leucocyte telomere length (LTL)

patients will be assessed LTL to see if there is correlation with body mass index, triglycerides, and skin aging

Diagnostic Test: blood draw

p16

patients will be assessed p16 to see if there is correlation with body mass index, triglycerides, and skin aging

Diagnostic Test: blood draw

Interventions

blood drawDIAGNOSTIC_TEST

PCR method to see leucocyte telomere length

leucocyte telomere length (LTL)p16

Eligibility Criteria

Age31 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

people with age from 31- 61 years

You may qualify if:

  • female aged 31-61 years
  • healthy
  • willing to participate in the study

You may not qualify if:

  • history of diseases (heart, kidney, liver)
  • pregnant or breastfeeding patientes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Irma Bernadette Sitohang, Prof IBSS Bernadette Sitohang, Proffesor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.DVE, Subsp. D.K.E

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 16, 2025

Study Start

February 5, 2025

Primary Completion

May 20, 2025

Study Completion

August 20, 2025

Last Updated

January 16, 2025

Record last verified: 2024-12

Locations