Aging SkinLTLP16NCT06779032
Clinical Profile of Skin Aging Based on Dermoscopy Photoaging Scale and Glogau Scale - Study of Leucocyte Telomere Length, Biomarker P16, and Body Mass Index
An observational study of Aging Skin and Body Mass Index, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 31 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Skin, Body Mass Index, Cellular Senescence
- What is being tested?
- blood draw
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Feb 2025to 20 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: people with age from 31- 61 years
Who may be able to join
- female aged 31-61 years
- healthy
- willing to participate in the study
Who cannot join
- history of diseases (heart, kidney, liver)
- pregnant or breastfeeding patientes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Irma Bernadette Sitohang, Prof IBSS Bernadette Sitohang, Proffesor contact
Indonesia1 site
Universitas Indonesia
Jakarta, DKI Jakarta, 10430
Irma Bernadette Sitohang, Proffessor, +62818130761, irma_bernadette@yahoo.com
About this study
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:
- What is the photoaging profile based on clinical examination results in skin aging cases?
- What is the photoaging profile based on DPAS scores in skin aging cases?
- What is the leucocyte telomere length profile in skin aging cases?
- What is the relationship between leucocyte telomere length and clinical examination in skin aging cases?
- What is the relationship between leucocyte telomere length and DPAS degree in skin aging cases?
- 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?
- What is the skin aging profile based on the Glogau and DPAS scales in a population with Fitzpatrick III-V skin types?
- 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?
- 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?
Read the detailed description
Skin aging is a process of decreasing the structure and physiological function of the skin that significantly increases in the 4th and 5th decades of age. The skin is the largest organ which is one-sixth of the total body weight in humans. One of the functions of the skin is as a protective organ that borders the external environment of the body, therefore, indicators of aging can be clearly seen on the skin. Some clinical manifestations of photoaging are wrinkles, rough, dry skin, telangiectasis, precancerous lesions, and changes in skin pigmentation. Photoaging assessment was first proposed in 1996 by Dr. Richard Glogau. The Glogau scale assesses photoaging based on clinical assessments which are grouped into 4 categories, namely types I, II, III, and IV. There is no literature on the validity and reliability of the Glogau scale, especially in individuals with Fitzpatrick skin types III and IV. Asian populations, especially those with Fitzpatrick skin types III, IV, and V, tend to experience pigmentation problems such as post-inflammatory hyperpigmentation and melasma. A study by Du et al found that Indonesian women, in particular, consider pigmentation and skin color imbalance as a major problem. Skin aging problems can affect patients' self-confidence and quality of life, although they are not life-threatening. The number of skin aging cases increased from 4.8% in 2021 to 11.5% in 2023, according to outpatient visit data at the Cosmetic Dermatology Polyclinic, KSM Dermatology and Venereology (DV) FKUI-RSCM. Along with the development of medical technology, in 2013 a photoaging evaluation instrument using dermoscopy was created, namely the dermoscopy photoaging scale (DPAS). The study was conducted in Istanbul with research subjects who mostly had Fitzpatrick skin types II and III. Dermoscopy findings assessed are manifestations of clinical photoaging such as skin discoloration, skin atrophy, telangiectasis, actinic keratosis, senile comedones, and wrinkles. The score is calculated based on specific dermoscopic findings in 4 facial regions, namely the forehead, chin, and both cheeks, which are then added up to a maximum score of 44. Dermoscopic evaluation as a simple and non-invasive diagnostic tool is more objective than clinical assessment. Assessment using DPAS is easy to use, can be applied in various situations and the score can be calculated quickly. Dermoscopic examination results will be compared with leucocyte telomere length (LTL) examination. Telomere shortening can cause cell aging, and from various studies, this has been studied as a marker of aging and a risk factor for age-related diseases. Telomere shortening accelerates skin aging. Clinically, skin aging is associated with reduced skin barrier function, poor wound healing, increased inflammation, disturbed water and temperature homeostasis, and increased susceptibility to skin disorders, including skin cancer. The main characteristics of aging, which are found in all parts of the body, are interconnected with each other, characterized by progressive loss of physiological integrity, genome instability, decreased telomere length, epigenetic changes, loss of proteostasis, decreased nutrient regulation, mitochondrial dysfunction, cellular senescence, stem cell exhaustion, and impaired intercellular communication.
Cellular senescence is considered one of the main characteristics of aging, which is defined as a growth arrest mediated by cell cycle regulators p53, p21, and p16. P16, has an important role in controlling the retinoblastoma tumor suppressor protein. Senescent cells that are positive for p16 accumulate in aging tissues including the skin.
The lack of clarity in the results of the correlation between p16 and skin aging assessed clinically using the Glogau scale and dermoscopy with the DPAS scale, has encouraged researchers to conduct a study to see the results of the levels of these cellular aging biomarkers in the Indonesian population. The results of the study are also expected to be able to correlate the p16 biomarker with clinical skin aging experienced at various ages in men and women. Several factors such as body mass index (BMI), waist circumference, triglycerides, can affect skin aging. A person with overweight or obese BMI has a changed skin structure compared to a person with normal BMI. People with obesity have a less well-organized skin collagen structure caused by degradation of collagen fibers and these dermal changes are irreversible. In obesity, skin-resident and systemic adipose tissue secrete several factors and increase inflammation and have a detrimental effect on facial aging.
Waist circumference is part of the adiposity indicator parameters other than BMI. Facial aging is related
- Being tested
- blood draw
- Keywords
- skin aging, body mass index, triglycerides, waist circumference, cellular senescene, p16
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawDiagnostic test
PCR method to see leucocyte telomere length
blood drawDiagnostic test
PCR method to see p16
| Study group | Role | What they receive |
|---|---|---|
| leucocyte telomere length (LTL) | patients will be assessed LTL to see if there is correlation with body mass index, triglycerides, and skin aging Receives: Diagnostic Test: blood draw | |
| p16 | patients will be assessed p16 to see if there is correlation with body mass index, triglycerides, and skin aging Receives: Diagnostic Test: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
profile of leucocyte telomere length
profile of leucocyte telomere length in skin aging
Measured: 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
Measured: 1 year
Profile of body mass index
checking BMI to see if there is correlation so skin aging
Measured: 1 year
profile of p16
checking p16 as a cellular senescence to skin aging
Measured: 1 year
profile of waist circumference
Waist circumferemce will be checked, to see if there is correlation with skin aging
Measured: 1 year
profile triglycerides
triglycerides will be checked, to see if there is correlation with skin aging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start5 Feb 2025 (estimated)
- Primary completion20 May 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging SkinStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779032
- Sponsor's protocol ID
- LTLP16
- Acronym
- LTLP16
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile of Skin Aging Based on Dermoscopy Photoaging Scale and Glogau Scale - Study of Leucocyte Telomere Length, Biomarker P16, and Body Mass Index
- ClinicalTrials.gov ID
- NCT06779032
- Acronym / sponsor ID
- LTLP16 / LTLP16
- Keywords
- skin aging, body mass index, triglycerides, waist circumference, cellular senescene, p16
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Feb 2025 (estimated)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the photoaging profile based on clinical examination results in skin aging cases?
- What is the photoaging profile based on DPAS scores in skin aging cases?
- What is the leucocyte telomere length profile in skin aging cases?
- What is the relationship between leucocyte telomere length and clinical examination in skin aging cases?
- What is the relationship between leucocyte telomere length and DPAS degree in skin aging cases?
- 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?
- What is the skin aging profile based on the Glogau and DPAS scales in a population with Fitzpatrick III-V skin types?
- 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?
- 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?
Detailed description
Skin aging is a process of decreasing the structure and physiological function of the skin that significantly increases in the 4th and 5th decades of age. The skin is the largest organ which is one-sixth of the total body weight in humans. One of the functions of the skin is as a protective organ that borders the external environment of the body, therefore, indicators of aging can be clearly seen on the skin. Some clinical manifestations of photoaging are wrinkles, rough, dry skin, telangiectasis, precancerous lesions, and changes in skin pigmentation. Photoaging assessment was first proposed in 1996 by Dr. Richard Glogau. The Glogau scale assesses photoaging based on clinical assessments which are grouped into 4 categories, namely types I, II, III, and IV. There is no literature on the validity and reliability of the Glogau scale, especially in individuals with Fitzpatrick skin types III and IV. Asian populations, especially those with Fitzpatrick skin types III, IV, and V, tend to experience pigmentation problems such as post-inflammatory hyperpigmentation and melasma. A study by Du et al found that Indonesian women, in particular, consider pigmentation and skin color imbalance as a major problem. Skin aging problems can affect patients' self-confidence and quality of life, although they are not life-threatening. The number of skin aging cases increased from 4.8% in 2021 to 11.5% in 2023, according to outpatient visit data at the Cosmetic Dermatology Polyclinic, KSM Dermatology and Venereology (DV) FKUI-RSCM. Along with the development of medical technology, in 2013 a photoaging evaluation instrument using dermoscopy was created, namely the dermoscopy photoaging scale (DPAS). The study was conducted in Istanbul with research subjects who mostly had Fitzpatrick skin types II and III. Dermoscopy findings assessed are manifestations of clinical photoaging such as skin discoloration, skin atrophy, telangiectasis, actinic keratosis, senile comedones, and wrinkles. The score is calculated based on specific dermoscopic findings in 4 facial regions, namely the forehead, chin, and both cheeks, which are then added up to a maximum score of 44. Dermoscopic evaluation as a simple and non-invasive diagnostic tool is more objective than clinical assessment. Assessment using DPAS is easy to use, can be applied in various situations and the score can be calculated quickly. Dermoscopic examination results will be compared with leucocyte telomere length (LTL) examination. Telomere shortening can cause cell aging, and from various studies, this has been studied as a marker of aging and a risk factor for age-related diseases. Telomere shortening accelerates skin aging. Clinically, skin aging is associated with reduced skin barrier function, poor wound healing, increased inflammation, disturbed water and temperature homeostasis, and increased susceptibility to skin disorders, including skin cancer. The main characteristics of aging, which are found in all parts of the body, are interconnected with each other, characterized by progressive loss of physiological integrity, genome instability, decreased telomere length, epigenetic changes, loss of proteostasis, decreased nutrient regulation, mitochondrial dysfunction, cellular senescence, stem cell exhaustion, and impaired intercellular communication.
Cellular senescence is considered one of the main characteristics of aging, which is defined as a growth arrest mediated by cell cycle regulators p53, p21, and p16. P16, has an important role in controlling the retinoblastoma tumor suppressor protein. Senescent cells that are positive for p16 accumulate in aging tissues including the skin.
The lack of clarity in the results of the correlation between p16 and skin aging assessed clinically using the Glogau scale and dermoscopy with the DPAS scale, has encouraged researchers to conduct a study to see the results of the levels of these cellular aging biomarkers in the Indonesian population. The results of the study are also expected to be able to correlate the p16 biomarker with clinical skin aging experienced at various ages in men and women. Several factors such as body mass index (BMI), waist circumference, triglycerides, can affect skin aging. A person with overweight or obese BMI has a changed skin structure compared to a person with normal BMI. People with obesity have a less well-organized skin collagen structure caused by degradation of collagen fibers and these dermal changes are irreversible. In obesity, skin-resident and systemic adipose tissue secrete several factors and increase inflammation and have a detrimental effect on facial aging.
Waist circumference is part of the adiposity indicator parameters other than BMI. Facial aging is related
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| leucocyte telomere length (LTL) | – | Diagnostic Test: blood drawpatients will be assessed LTL to see if there is correlation with body mass index, triglycerides, and skin aging |
| p16 | – | Diagnostic Test: blood drawpatients will be assessed p16 to see if there is correlation with body mass index, triglycerides, and skin aging |
Who may qualify
- Ages
- 31 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- people with age from 31- 61 years
Key inclusion criteria (3 listed)
- female aged 31-61 years
- healthy
- willing to participate in the study
Key exclusion criteria (2 listed)
- history of diseases (heart, kidney, liver)
- pregnant or breastfeeding patientes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawPCR method to see leucocyte telomere length | Diagnostic test | leucocyte telomere length (LTL), p16 |
| blood drawPCR method to see p16 | Diagnostic test | leucocyte telomere length (LTL), p16 |
Primary outcome
profile of leucocyte telomere length
Time frame: 1 year
profile of leucocyte telomere length in skin aging
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
Profile of body mass index
Time frame: 1 year
checking BMI to see if there is correlation so skin aging
profile of p16
Time frame: 1 year
checking p16 as a cellular senescence to skin aging
profile of waist circumference
Time frame: 1 year
Waist circumferemce will be checked, to see if there is correlation with skin aging
profile triglycerides
Time frame: 1 year
triglycerides will be checked, to see if there is correlation with skin aging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irma Bernadette Sitohang, Prof IBSS Bernadette Sitohang, Proffesor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging Skin and Body Mass Index, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irma Bernadette Sitohang, Prof IBSS Bernadette Sitohang, Proffesor (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
profile of leucocyte telomere length (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.