Can subtle changes in skin hydration be used to help treat dry skin conditions and detect skin cancers?

Not Applicable

Completed

• Conditions: Current condition as of 20/03/2023: 1. Benign dry skin conditions 2. Known or suspected skin cancer (either confirmed basal cell carcinoma and/or suspected malignant melanoma) 3. Benign pigmented skin lesions (including seborrheic keratosis and others) Previous condition: Dry skin conditions (e.g. eczema, psoriasis, scars); Skin and Connective Tissue Diseases

• Registration Number: ISRCTN14066634
• Lead Sponsor: niversity Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-11
• Study Completion: 2023-03-15
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Current participant inclusion criteria as of 20/03/2023:
Study arm 1 (Benign dry skin condition) – patients, members of the public or NHS staff:
1. Aged 18 years and over
2. Diagnosed with dry skin conditions (e.g. eczema, psoriasis, scars etc.)
3. Capacity to give informed consent

Study arm 2 (Known or Suspected Skin Cancer) – patients only:
1. Aged 18 years and over
2. Patient to have ONE of the following TWO diagnoses:
2.1. Confirmed or suspected basal cell carcinoma (BCC) skin cancer, for example: incompletely excised BCC with histologically proven radial margin involvement, OR biopsy-proven BCC (e.g., punch biopsy or incision biopsy); OR clinically diagnosed BCC
2.2. Clinically suspicious pigmented skin lesion (suspected melanoma) with a plan for surgical biopsy
3. Capacity to give informed consent

Study arm 3 (Clinically Benign Pigmented Lesions) – patients only:
1. Aged 18 years and over
2. Diagnosed with a clinically non-suspicious pigmented skin lesion (seborrhoeic keratosis or
other) referred by GP on a suspected skin cancer diagnostic pathway (2WW)
3. Capacity to give informed consent

Previous participant inclusion criteria:
Study arm 1 (dry skin condition):
1. Aged 18 years and over
2. Diagnosed with dry skin conditions (e.g. eczema, psoriasis, scars)
3. Capacity to give informed consent

Study arm 2 :
1. Aged 18 years and over
2. Confirmed or suspected skin cancer (incompletely excised BCC with histologically proven radial margin involvement, biopsy-proven BCC or pigmented lesions suspicious of malignant melanoma)
3. Diagnosed with an incompletely excised basal cell carcinoma skin cancer (either radial margin involvement on primary excision or following diagnostic punch biopsy).
4. Clinically suspicious pigmented skin lesion (suspected melanoma) with a plan for surgical biopsy
5. Capacity to give informed consent

Exclusion Criteria

Current participant exclusion criteria as of 20/03/2023:
Study Arm 1 (Benign dry skin condition) – patients, members of the public or NHS staff:
1. Previous allergy or sensitivity to propriety emollients in common usage (e.g. E45®, Aveeno®, Doublebase®etc.)
2. Area of interest is inaccessible to the THz skinometer for scanning

Study arm 2 (Known or suspected Skin Cancer) – patients only:
Area of interest is inaccessible to the THz skinometer for scanning

Study arm 3 (Clinically Benign Pigmented Lesions) – patients only:
Area of interest is inaccessible to the THz skinometer for scanning

Previous participant exclusion criteria:
Exclusion criteria (study arm 1, benign dry skin condition):
Previous allergy or sensitivity to propriety emollients in common usage (e.g. E45®, Aveeno®, Doublebase®)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients screened, eligible, recruited, withdrawn and retained during the study, recorded through screening activity at the end of the study