Skin Ageing Signatures and Cancer

NCT ID: NCT03265678

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-02

Study Completion Date

2018-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to identify genetic patterns in normal ageing skin in order to better understand age-related changes.

Data has suggested that skin ageing has a genetic basis and past studies have identified genes that promote skin aging due to sun exposure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will use new tools in an attempt to understand the small changes that take place in skin and may be linked to skin ageing either due to age or the effect of the sun. Some data suggests that these changes may have a genetic basis.

In this study, the doctor will use a clinical scale to assess the participants skin type, the scale will range from 1-5 with 1 being fairer skin types and 5 being darker skin types. The doctors will select 10 female participants who meet the required skin types (1-4), aged between 55 and 65 years who attend clinics for reasons other than skin cancer or other skin diseases. 5 of these patients will have high levels of skin ageing and 5 will have low levels of skin ageing as defined by a set of pre-defined criteria. The criteria will be identified by examining the skin on the participants face and forearm. The study sponsor will collect skin and blood samples from all participants in the high and low skin ageing groups and these will be sent to a specialist laboratory for DNA and RNA analysis (genetic analysis).

The study sponsor hope that this will help us understand the effects of ageing on skin's normal functions but also help us interpret results coming out of other genetic studies in skin cancer. This information will help to better understand the changes linked with the development of skin cancer.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skin Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm

Registered participants will undergo a clinical assessment to determine whether they have high or low levels of skin ageing. The study will recruit 5 subjects with low levels of skin ageing and 5 subjects with high levels of skin ageing. Recruited patients will undergo skin punch biopsies, blood sampling and collection of lifestyle data.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Able to give written informed consent prior to admission to this study.
2. Female aged between 55 and 65 years.
3. Willing and able to comply with clinical/photographic assessment and laboratory tests

Exclusion Criteria

1. Previous history of skin cancer, active inflammatory or other skin condition that in the opinion of the investigator may affect the skin ageing assessment.
2. Feverish symptoms which lasted for ≥48 hours prior to study entry.
3. Currently suffering from or having suffered during the last month, with any common systemic disease except arterial hypertension.
4. Received any of the following treatment for more than 6 months during the last two years: hypo or hyperthyroidism treatment, corticoids, non-steroids anti-inflammatory, antihistamines, immunosuppressive treatments, diuretics, antibiotics, anticoagulants, beta blockers.
5. Currently experiencing or having experienced in the last two months prior to study entry problems affecting the skin of the face or forearm for instance acne, eczema, psoriasis, seborroheic dermatitis, herpes zoster.
6. Currently receiving or having received in the last two months prior to study entry any of the following dermatological treatments for more than 8 days: hormone based cream, retinoid based facial cream, \> 8% concentration alpha hydroxy acid based cream, topical steroids, antibiotics and antifungals
7. Previous facial aesthetic treatments such as: lifting, chemical peeling, dermabrasion, electrocoagulation, laser, sclerotherapy, reconstructive surgery, botox injection, filler injection.
8. Currently using a hormone based cream that is applied on the forearm for hormonal replacement therapy.
9. Have had a change in skin colour during within one month prior to study entry due to sun exposure
10. Had a session of UV therapy for treatment purposes or in a beauty salon within one month prior to study entry.
11. Use of a self-tanning product
Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Edinburgh

OTHER

Sponsor Role collaborator

Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Prof Catherine Harwood

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barts Health NHS Trust

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11701

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.