NCT06501547

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

June 2, 2024

Last Update Submit

July 9, 2024

Conditions

AgingSkin Laxity

Keywords

DermoscopyDermoscopic photoaging scale (DPAS)Glogau scaleLeucocyte telomere length (LTL)PhotoagingSkin agingTelomereUltraviolet (UV)

Outcome Measures

Primary Outcomes (3)

  • profile of leucocyte telomere length

    profile of leucocyte telomere length in skin aging

    1 year

  • Profile of skin examination from Glogau scale

    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)

    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

Study Arms (2)

lifestyle counseling

EXPERIMENTAL

patient will be asked about the mean of sun exposure per week

Genetic: Leucocyte Telomere Length from blood draw

Clinical examination

EXPERIMENTAL

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

Interventions

Leucocyte Telomere Length from blood drawGENETIC

blood draw, PCR method to see leucocyte telomere length

Clinical examinationlifestyle counseling

Eligibility Criteria

Age29 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • pregnant or breastfeeding
  • have disease or genetic problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Central Study Contacts

Irma Bernadette Sitohang, Prof

CONTACT

+62818130761irma_bernadette@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.KK (K)

Study Record Dates

First Submitted

June 2, 2024

First Posted

July 15, 2024

Study Start

October 1, 2023

Primary Completion

April 30, 2024

Study Completion

September 1, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

provide positive impact for Cipto Mangunkusumo National Hospital and worldwide

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
1 year

Locations

ID(1)