NCT03265678

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 2, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2018

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

August 25, 2017

Last Update Submit

April 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recruitment of 10 patients with high or low skin ageing scores and collection of normal sun exposed and non-sun exposed skin and blood for genetic analysis.

    Identify a genomic/transcriptomic molecular signature for skin ageing by correlation of whole genome sequencing and transcriptomic profiles of normal skin and clinically evaluated skin ageing scores

    1 Year

Secondary Outcomes (1)

  • Whole genome sequencing and transcriptomic analysis of normal skin samples

    1 Year

Study Arms (1)

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.

Eligibility Criteria

Age55 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants will be approached for the study
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential participants will be identified amongst patients attending outpatient clinics in dermatology, ophthalmology and other general medical specialities for reasons other than skin cancer or inflammatory skin disease. If required, volunteers will also be recruited by advertising from amongst staff within the hospital and Queen Mary University of London. Participants will be identified by the dermatology consultant or research fellow working on this study.

You may qualify if:

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

You may not qualify if:

  • Previous history of skin cancer, active inflammatory or other skin condition that in the opinion of the investigator may affect the skin ageing assessment.
  • Feverish symptoms which lasted for ≥48 hours prior to study entry.
  • Currently suffering from or having suffered during the last month, with any common systemic disease except arterial hypertension.
  • 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.
  • 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.
  • 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
  • Previous facial aesthetic treatments such as: lifting, chemical peeling, dermabrasion, electrocoagulation, laser, sclerotherapy, reconstructive surgery, botox injection, filler injection.
  • Currently using a hormone based cream that is applied on the forearm for hormonal replacement therapy.
  • Have had a change in skin colour during within one month prior to study entry due to sun exposure
  • Had a session of UV therapy for treatment purposes or in a beauty salon within one month prior to study entry.
  • Use of a self-tanning product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin and blood samples

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Prof Catherine Harwood

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 29, 2017

Study Start

June 2, 2017

Primary Completion

January 22, 2018

Study Completion

January 22, 2018

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations