SkIN hydrAtion Evaluation With TeRAhertz Scanning

NCT05121207 | Completed

• 1 other identifier: JH464519
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Medical imaging commonly involves the use of radiation, such as x-rays, that can give detailed images of internal structures of the body but can carry a small risk of tissue damage due to the radiation involved. As such, the number of x-rays and computed tomography (CT) scans that an individual can have has to be minimised. Methods have recently been developed that make use of electromagnetic radiation for imaging purposes at terahertz (THz) frequencies, the region of the spectrum between millimetre wavelengths and infrared. Terahertz spectroscopic imaging uses low power levels such that adverse effects on tissues are insignificant and is safe for in vivo imaging of humans \[1\]. The terahertz region is between the radio frequency region and the optical region generally associated with lasers. Both the IEEE RF safety standard and the ANSI Laser safety standard have limits into the terahertz region. The focus of this project is to investigate THz spectroscopic imaging as a new and powerful tool for analysing skin properties, termed "THz skinometry". The novelty in this project lies in tailoring the instrumentation and algorithms of THz scanning to accurately measure properties of human skin (e.g. hydration levels and skin thickness) in vivo. The customised non-contact and pressure-controlled contact THz probes developed will be able to do spectroscopic measurements of skin in vivo at the molecular level. This will be the first demonstration of in vivo THz imaging of skin globally and will facilitate quantitative characterisation of skin in a way that has hitherto not been possible and could lead to a step change in THz technology usage (similar to that currently used in airport security scanners).

Conditions

Cancer; Skin Cancer; Dry Skin; Eczema; Medical Device Site Eczema

Keywords

medical device

Outcome Measures

Primary Outcomes (1)

• Feasability

  The primary objective will be to explore the feasibility of the intervention delivery by looking at the number of people screened, recruited and consented into the study.

  12 months

Secondary Outcomes (2)

• Skin hydration

  12 months

• Presence of skin cancer

  12 months

Study Arms (2)

Dry skin condition

OTHER

2\. The second arm will consist of 50 patients with benign dry skin conditions (eczema, psoriasis, skin grafts, scars etc.) and will compare the water content of their skin before and after application of a propriety emollients in common usage (e.g. E45®, Aveeno®, Doublebase®). This will add to the existing dataset that has been recorded from healthy non-patient volunteers (unpublished data, University of Warwick). This may help to guide patient-specific emollient selection in the future.

Device: Terahertz scanning

Skin cancer

OTHER

1\. One arm will consist of 100 patients with known or suspected skin cancer (skin cancer defined as: incompletely excised BCC with histologically proven radial margin involvement; biopsy proven BCC, or pigmented lesions suspicious of malignant melanoma). Images will be taken in the clinic prior to planned skin surgery and later compared to the formal histology results after the primary (melanoma) or residual (BCC) tumour has been removed.

Device: Terahertz scanning

Interventions

Terahertz scanning DEVICE

Short scans using Terahertz device

Dry skin condition; Skin cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and over
• Diagnosed with dry skin conditions (e.g. eczema, psoriasis, scars etc.)
• Capacity to give informed consent
• Confirmed or suspected skin cancer (incompletely excised BCC with histologically proven radial margin involvement, biopsy proven BCC or pigmented lesions suspicious of malignant melanoma) .
• Diagnosed with an incompletely excised basal cell carcinoma skin cancer (either radial margin involvement on primary excision or following diagnostic punch biopsy).
• Clinically suspicious pigmented skin lesion (suspected melanoma) with a plan for surgical biopsy
• Capacity to give informed consent

You may not qualify if:

• Study Arm 1 ( benign dry skin condition) • Previous allergy or sensitivity to propriety emollients in common usage (e.g. E45®, Aveeno®, Doublebase®etc.).

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• University of Warwick: collaborator

Study Sites (1)

University Hospital Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV22DX, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Skin Neoplasms; Eczema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Skin cancer group and a dry skin condition group

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: November 16, 2021
• Study Start: February 28, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

GB (1)