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
Conditions
Interventions
Current interventions as of 20/03/2023:
The SINATRA study will collect preliminary pilot data from patient volunteers in a two-arm proof of concept study. One arm (group A) will consist of 50 patients
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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®)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients screened, eligible, recruited, withdrawn and retained during the study, recorded through screening activity at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/03/2023: Objective difference in skin hydration between normal skin and dry skin conditions, benign pigmented skin lesions, skin containing residual basal cell carcinoma and skin containing malignant melanoma. For the dry skin arm, water content will be measured using THz skinometer scan data to observe the differences in pre- and post-emollient application. For cancer and benign pigmented skin lesion arms, skin hydration will be measured using THz skinometer scan data to investigate whether this may indicate the presence of residual basal cell carcinoma after primary excision, primary BCC or the localised inflammation caused by melanoma skin cancer compared to benign variants (seborrheic keratosis or other). Previous secondary outcome measures: Objective difference in skin hydration between normal skin, benign skin conditions, skin containing residual basal cell carcinoma and skin containing malignant melanoma, measured using THz skinometer scan data with formal reported histological analysis as part of the standard skin cancer management pathway, measured for arm A before histology is taken and for arm B before and after applying the chosen emollient. | — |
Countries
England, United Kingdom
Outcome results
None listed