A patch test study of STS01 in healthy volunteers
| ISRCTN | ISRCTN84166928 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84166928 |
| EudraCT/CTIS number | 2022-001272-34 |
| IRAS number | 1005742 |
| Secondary identifying numbers | AN3476/SOT03, IRAS 1005742 |
- Submission date
- 11/05/2022
- Registration date
- 08/08/2022
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
In order to address the factors associated with poor tolerability and compliance with the administration of current preparations, the investigational medicinal product (IMP) will be a controlled release, cream-based, formulation STS01. The silicon atoms are ‘activated’ (electrically charged) to enable a controllable ‘honeycomb’ pore structure as a drug delivery mechanism with the potential to offer enhanced targeting and release characteristics. The main aim of this study is to look at whether a new controlled release formulation of STS01 has a beneficial effect on the skin irritation and skin staining potential that is seen with normal cream.
Who can participate?
Healthy volunteers aged 18 – 70 years
What does the study involve?
The study will comprise an initial open, prolonged exposure study (safety phase) to inform safety for the repeated application study (repeated phase). The safety phase is designed to determine the skin irritancy of each of the four topical formulations in healthy volunteer subjects, compared to the Base Formulation (with no dithranol) and E45 Dermatological Cream. The study will involve a progressive patch test with an increasing duration of exposure of up to 8 hours with follow-up assessments at 24, 48 and 72 hours. This approach is designed to minimise the exposure risk for the participants. Such an approach has been used previously to determine the irritancy of chemicals classified as irritants with no risk to participants. The repeat phase will be a double-blind, randomised study of the same set of creams, which will be applied to the lower back area of the participants. The creams will be applied to the test sites for periods of 1 hour on seven consecutive days with assessments on Days 1-13 and Day 16. Any clinical signs of cutaneous irritation (or any other clinical signs) will be recorded.
What are the possible benefits and risks of participating?
This approach is designed to minimise the exposure risk for the participants. Such an approach has been used previously to determine the irritancy of chemicals classified as irritants with no risk to participants. Possible side effects from using other dithranol products include skin irritation and staining. The dithranol/ProSilic® cream formulation controls the drug release from the cream preparation and reduces this risk. Participants with an allergy likely to interfere with the study are excluded. Participants will need to attend the Phase I unit clinic up to a maximum of four occasions. Participants who participated in the safety phase and had dithranol formulations applied to the skin may not participate in the repeated phase.
Where is the study run from?
Soterios Ltd (UK)
When is the study starting and how long is it expected to run for?
May 2022 to December 2022
Who is funding the study?
Soterios Ltd (UK)
Who is the main contact?
David Fleet
davidfleet@manentia.co.uk
Contact information
Scientific
Soterios Ltd
East Grimstead
Salisbury
SP5 3RT
United Kingdom
| Phone | +44 (0)1722 712972 |
|---|---|
| davidfleet@manentia.co.uk |
Principal Investigator
Pendragon House
Caxton Place
Pentwyn
Cardiff
CF23 8XE
United Kingdom
| Phone | +44 (0)2920 625686 |
|---|---|
| info@cutest.co.uk |
Study information
| Study design | Double-blind randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A repeat open application patch test (ROAT) using a new controlled release formulation of STS01 cream in healthy volunteer subjects, preceded by a preliminary safety phase |
| Study hypothesis | The primary objective is to investigate the irritancy and staining potential with a new controlled release formulation of STS01. The study will comprise an initial open, prolonged exposure study (“safety phase”) to inform safety for the repeated application study (“repeated phase”). |
| Ethics approval(s) | Approved 11/07/2022, Wales REC 1 (Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920785738; wales.REC1@wales.mhs.uk), ref: 22/WA/0151 |
| Condition | Healthy volunteer study - the treatment is for alopecia areata |
| Intervention | Participants are randomised to a patch test of STS01 topical cream in strengths of 0.0%, 0.25%, 0.5%, 1% and 2% w/w or a control treatment (E45 Dermatological Cream); applied once. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | STS01 |
| Primary outcome measure | Assessment of test product contact with the skin using appropriate ranking scales, chromameter measurements and thermometry measurements. Staining of the application area will also be assessed by imaging (camera or TiVi Imaging System). Cream application sites will be assessed after a minimum of 10 minutes and a maximum of 30 minutes to allow any reactions due to the removal of the tape and test chamber to subside. The test chambers will be removed and assessed at 1, 2, 4 and 8 hours. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 09/05/2022 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 59 |
| Participant inclusion criteria | 1. Subjects who are in the age range 18 – 70 years 2. Subjects with no significant concurrent illnesses or skin disease 3. Subjects who have signed the consent form after the nature of the study has been fully explained |
| Participant exclusion criteria | 1. Pregnant or breastfeeding or lactating females or females who have given birth in the last 6 weeks 2. Subjects with a diagnosis of psoriasis, even if disease is not currently active 3. Subjects who participated in the safety phase and had dithranol formulations applied to the skin may not participate in the repeated phase 4. Subjects with atopy, self-diagnosed sensitive skin, or other dermatoses 5. Subjects who take any systemic or topical medication likely to interfere with the study e.g., anti-inflammatory drugs such as systemic steroids 6. Subjects who have taken part in a Health Research Authority or MHRA regulated clinical trial (e.g., at a hospital or Phase I unit) within the previous 8 weeks 7. Subjects who have taken part in a study involving the test site during the previous 4 weeks 8. Subjects with a recent history (previous 12 months) of significant skin disease requiring medical intervention, e.g., Dermatology outpatient appointment 9. Subjects with an allergy likely to interfere with the study 10. Subjects with a recent history of/or evidence of alcohol, substance or drug abuse |
| Recruitment start date | 09/06/2022 |
| Recruitment end date | 31/12/2022 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Caxton Place
Pentwyn
Cardiff
CF23 8XE
United Kingdom
Sponsor information
Industry
East Grimstead
Salisbury
SP5 3RT
England
United Kingdom
| Phone | +44 (0)1722 712972 |
|---|---|
| davidfleet@manentia.co.uk |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Internal report 3. Conference presentation 4. Submission to regulatory authorities |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | version 1 | 23/12/2024 | 17/01/2025 | No | No |
Additional files
Editorial Notes
17/01/2025: The basic results have been uploaded as an additional file.
27/11/2024: Incorrect ethics approval and total final enrolment corrected.
22/01/2024: Ethics approval and total final enrolment added.
08/08/2022: Received combined approval from the HRA on 22/07/2022, as notified in the HRA spreadsheet on 08/08/2022.
11/05/2022: Trial's existence confirmed by the HRA.
