Alopecia AreataPhase 2SOT01NCT06402630
A Phase 2 Placebo Controlled, Clinical Trial Designed to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA)
A Phase 2 study testing STS01 in people with Alopecia Areata, run by Soterios Ltd at 9 sites in United Kingdom.
Trial summary
A Phase 2 double-blind, multi-site, placebo-controlled, parallel-group design to assess the efficacy, safety and dose-response characterisation of STS-01 for the treatment of mild- moderate alopecia areata. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- STS01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 23 Mar 2022to 1 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active alopecia areata (less than 50% SALT score, present for at least 6 months)
- Not currently receiving treatment for hair loss
- Eighteen years of age or more
- Affected skin with normal appearance and no grossly evident epidermal alteration such as scaling or follicular abnormalities
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
St Lukes Hospital
Bradford, Little Horton Lane, BD5 0NA
Royal Alexandra Children's Hospital
Brighton, BN2 5BE
University Hospital Coventry & Warwickshire
Coventry, CV2 2DX
Queen Margaret Hospital
Glasgow, Dunfirmline, KY12 0SU
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
Queen Anne Street Medical Centre Limited
London, W1G 8HU
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
Salford Royal Hospital
Salford, M6 8HD
About this study
Official title: A Phase 2 Double-blind, Multicentre, Placebo Controlled, Parallel Group Design to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA)
A Phase 2 double-blind, multi-site, placebo-controlled, parallel-group design to assess the efficacy, safety and dose-response characterisation of STS-01 for the treatment of mild- moderate alopecia areata.
Read the detailed description
STS-01 is being developed to address the need for an effective, safe and convenient non-steroidal topical treatment for mild-moderate alopecia areata. The product builds on a mechanism with a well-established safety profile in dermatology, and existing evidence of its effectiveness in this condition through targeting key relevant cytokines. STS-01 has been modified to maximise the effectiveness of this mechanism and offer a cosmetically elegant topical cream. The study aims to assess the effectiveness, safety and dose-response characteristics of STS-01 for the treatment of mild-moderate alopecia areata.
- Conditions
- Alopecia Areata
- Being tested
- STS01, Placebo
- Keywords
- alopecia areata, alopecia, areata, aa, autoimmune, hair loss, hair, autoimmune hair, follicle
- Medical subject headings
- Alopecia Areata, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STS01Drug
Participants are block randomised to be treated with 0.25%, 0.5%, 1.0%, 2% STS-01 or a matching placebo control topically once daily for 6 months with a 2-month follow up.
PlaceboDrug
Participants are block randomised to be treated with 0.25%, 0.5%, 1.0%, 2% STS-01 or a matching placebo control topically once daily for 6 months with a 2-month follow up.
| Study group | Role | What they receive |
|---|---|---|
| 0.25% Dose | Experimental | Once daily, STS-01 topical cream applied to affected area of the head Receives: Drug: STS01 |
| 0.5% Dose | Experimental | Once daily, STS-01 topical cream applied to affected area of the head Receives: Drug: STS01 |
| 1% Dose | Experimental | Once daily, STS-01 topical cream applied to affected area of the head Receives: Drug: STS01 |
| 2% Dose | Experimental | Once daily, STS-01 topical cream applied to affected area of the head Receives: Drug: STS01 |
| Placebo | Placebo comparator | Once daily, topical cream applied to affected area of the head (without API) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months
Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months. Targeting patients with <50 SALT (less than 50% hair loss).
Measured: 6 Months
Secondary outcomes (4)
Regrowth area measured by graphical measuring of the size of the patch
Regrowth area measured by graphical measuring of the size of the patch
Measured: 6 months
Global assessment using the Clinical Global Impression (CGI) score
Global assessment using the Clinical Global Impression (CGI) score
Measured: 6 Months
AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
Measured: 6 Months
AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start23 Mar 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soterios Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402630
- Sponsor's protocol ID
- SOT01
- Other IDs
- 2021-004145-20
- Acronym
- SOT01
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-blind, Multicentre, Placebo Controlled, Parallel Group Design to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA)
- ClinicalTrials.gov ID
- NCT06402630
- Acronym / sponsor ID
- SOT01 / SOT01
- Conditions
- Alopecia Areata
- Keywords
- alopecia areata, alopecia, areata, aa, autoimmune, hair loss, hair, autoimmune hair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Soterios LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 double-blind, multi-site, placebo-controlled, parallel-group design to assess the efficacy, safety and dose-response characterisation of STS-01 for the treatment of mild- moderate alopecia areata.
Detailed description
STS-01 is being developed to address the need for an effective, safe and convenient non-steroidal topical treatment for mild-moderate alopecia areata. The product builds on a mechanism with a well-established safety profile in dermatology, and existing evidence of its effectiveness in this condition through targeting key relevant cytokines. STS-01 has been modified to maximise the effectiveness of this mechanism and offer a cosmetically elegant topical cream. The study aims to assess the effectiveness, safety and dose-response characteristics of STS-01 for the treatment of mild-moderate alopecia areata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.25% Dose | Experimental | Drug: STS01Once daily, STS-01 topical cream applied to affected area of the head |
| 0.5% Dose | Experimental | Drug: STS01Once daily, STS-01 topical cream applied to affected area of the head |
| 1% Dose | Experimental | Drug: STS01Once daily, STS-01 topical cream applied to affected area of the head |
| 2% Dose | Experimental | Drug: STS01Once daily, STS-01 topical cream applied to affected area of the head |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily, topical cream applied to affected area of the head (without API) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active alopecia areata (less than 50% SALT score, present for at least 6 months)
- Not currently receiving treatment for hair loss
- Eighteen years of age or more
- Affected skin with normal appearance and no grossly evident epidermal alteration such as scaling or follicular abnormalities
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STS01Participants are block randomised to be treated with 0.25%, 0.5%, 1.0%, 2% STS-01 or a matching placebo control topically once daily for 6 months with a 2-month follow up. | Drug | 0.25% Dose, 0.5% Dose, 1% Dose, 2% Dose |
| PlaceboParticipants are block randomised to be treated with 0.25%, 0.5%, 1.0%, 2% STS-01 or a matching placebo control topically once daily for 6 months with a 2-month follow up. | Drug | Placebo |
Primary outcome
Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months
Time frame: 6 Months
Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months. Targeting patients with <50 SALT (less than 50% hair loss).
4 secondary outcomes
Regrowth area measured by graphical measuring of the size of the patch
Time frame: 6 months
Global assessment using the Clinical Global Impression (CGI) score
Time frame: 6 Months
AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
Time frame: 6 Months
AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STS01 in people with Alopecia Areata, run by Soterios Ltd at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.