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RecruitingNCT06501547Updated Jul 15, 2024

Association of Leucocyte Telomere Length With DPAS Score in Skin Aging

An interventional study of Leucocyte Telomere Length from blood draw in Aging and Skin Laxity, sponsored by Dr.dr.Irma Bernadette, SpKK (K). Recruiting at 1 site in Indonesia. Open to participants aged 29 Years to 61 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Dr.dr.Irma Bernadette, SpKK (K) · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
29 Years to 61 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Aging
  • Skin Laxity

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Keywords

  • Dermoscopy
  • Dermoscopic photoaging scale (DPAS)
  • Glogau scale
  • Leucocyte telomere length (LTL)
  • Photoaging
  • Skin aging
  • Telomere
  • Ultraviolet (UV)
03

Who can participate

Ages eligible
29 Years to 61 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnant or breastfeeding
  • have disease or genetic problem
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    lifestyle counseling

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

    Genetic: Leucocyte Telomere Length from blood draw

  • 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

Interventions

  • GeneticLeucocyte Telomere Length from blood draw

    blood draw, PCR method to see leucocyte telomere length

05

What researchers measure

Primary outcomes

  1. profile of leucocyte telomere length

    profile of leucocyte telomere length in skin aging

    Time frame: 1 year

  2. 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)

    Time frame: 1 year

  3. 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

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Universitas Indonesia
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — provide positive impact for Cipto Mangunkusumo National Hospital and worldwide

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06501547
Lead sponsor
Dr.dr.Irma Bernadette, SpKK (K)
Collaborators
Indonesian Medical Education and Research Institute
Responsible party
Dr.dr.Irma Bernadette, SpKK (K) (Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.KK (K), Indonesia University) — Sponsor-investigator
First posted
Jul 15, 2024
Start date
Oct 1, 2023
Primary completion
Apr 30, 2024
Completion
Sep 1, 2024 (estimated)
Last update
Jul 15, 2024

Study contacts

Irma Bernadette Sitohang, Prof
Contact
irma_bernadette@yahoo.com
+62818130761

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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