Herpes LabialisPhase 2MATCH-1NCT04539483
Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection
A Phase 2 study testing HDIT101 (blinded therapy), Photo documentation of orolabial herpes lesions and Completion of questionnaires (patient-reported outcomes) in people with Herpes Labialis, run by Heidelberg ImmunoTherapeutics GmbH at 5 sites in Germany.
Trial summary
This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo. HSV-1-positive patients with at least 6 orolabial herpes lesions in the last 12 months can be included. The patients need to present with 3 herpes lesions within a 9 months observation phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- HDIT101 (blinded therapy), Photo documentation of orolabial herpes lesions and Completion of questionnaires (patient-reported outcomes)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 761 participants
- Where
- 5 sitesGermany
- Study dates
- 8 Oct 2020to 31 May 2023
- 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
Main Inclusion Criteria:
- Ability to provide written, personally signed and dated informed consent
- Age ≥ 18 years
- Understanding, ability, and willingness to fully comply with study interventions and restrictions.
- Seropositive for HSV-1 at screening with a history of chronic recurrent orolabial herpes infection for at least 12 months with at least 6 orolabial recurrences in the last year.
- Three confirmed lesions within 9 months after enrolment.
- Willingness not to use any HSV-suppressant therapy except 5% aciclovir cream as optional standard of care
- Willingness to remove beard or lip piercings if lesion boundaries in this region cannot be evaluated and topical treatment of the entire lesion is compromised (according to judgement of investigator).
- Willingness to self-obtain daily swabs from the orolabial region, to provide photos of the lesions and to complete questionnaires during the study.
- Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator.
- Willingness to use contraceptive methods for 30 days after each treatment.
- Availability of a mobile phone, tablet, or other smart device with a camera, connection to the internet and willingness to use this device for documentation of patient-reported outcomes and photo upload.
Main Exclusion Criteria:
- Patients who do not develop at least 3 lesions of stage 3 or higher during the 9 months observation phase or do not develop any lesion within 150 days from enrolment visit.
- Herpes keratitis.
- Requirement for immunosuppressive therapy and/or steroids.
- Any known clinically relevant allergies to drugs or any history of severe allergic or anaphylactic reactions
- Positive HIV antibody screen, active hepatitis B virus or active hepatitis C virus infection.
- Treatment with an investigational drug in any clinical study within the last 30 days prior to enrolment in this study.
- Prior treatment with HDIT101, e.g. in this or another clinical study.
- Prior vaccination with an HSV type 1/2 vaccine (e.g. experimental) within the last 2 years prior screening.
- Pregnant or breast-feeding women.
- Prior malignant disease (except basal cell carcinoma in situ) if not successfully cured more than 5 years before enrolment.
- Patients who have abnormal skin conditions which are considered clinically significant according to the assessment of the investigator
- Any clinically relevant medical history or current physical or psychiatric illnesses/medical conditions that constitute an unacceptable risk for study participation or make the participant unlikely to fully complete the study in the judgment of the investigator. This especially applies to currently medicated psychiatric illnesses since this poses an additional risk for pharmacodynamic interaction with IMP.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
emovis GmbH
Berlin, 10629
Infektio Research GmbH & Co. KG
Frankfurt am Main, 60596
bioskin Prüfzentrum
Hamburg, 20095
ICH Study Center GmbH & Co. KG
Hamburg, 20146
Universitätsklinikum Heidelberg - Medizinische Klinik, Klinische Pharmakologie & Pharmakoepidemiologie
Heidelberg, 69120
About this study
Official title: A Randomised, Double-Blind Phase II Trial of Topical HDIT101 Versus Placebo in Patients With Chronic Recurrent HSV-1 Infection and Orolabial Lesion
This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo. HSV-1-positive patients with at least 6 orolabial herpes lesions in the last 12 months can be included.
The patients need to present with 3 herpes lesions within a 9 months observation phase. With the occurrence of the third lesion, the patients will enter the 12 months treatment phase and will be randomized in a 2:1 ratio to topical HDIT or placebo applied over 2 days. A potential fourth lesion will also be treated with the blinded study medication and additional lesions will be documented.
Read more
In a 12 months post-trial follow-up phase, further information on the occurence of lesions will be collected 4 times by phone.
Study duration per patient will be up to 21 months plus 12 months post-trial follow-up by phone. Patients need to come for study visits up to 9 times.
Read the detailed description
This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo.
Approximately 138 eligible patients will be randomised at a ratio of 2:1 to topical HDIT or corresponding placebo.
The trial consists of 3 parts: An observation phase (up to 9 months), a treatment phase of 12 months, and a post-trial follow-up phase of additional 12 months: The observation phase ensures that the patient develops a minimum number of lesions during the trial. In the 12 months treatment phase, blinded study treatment consisting of topical HDIT101 or placebo is applied to the patients at the first and second lesion episode. After completion of the treatment phase, patients are followed for additional 12 months for assessment of the development of further lesions (post-trial follow-up phase).
Observation phase (max. 9 months):
Eligible patients suffering from chronic recurrent herpes orolabialis for at least 12 months and reporting ≥ 6 lesions in the last 12 months can enter the observation phase. This part of the study serves for confirmation that patients develop a minimum number of 3 lesions within the 9 months observation period. No study treatment is applied in the observation phase, but standard-of-care treatment (SoC) can optionally be applied. Single swabs should additionally be taken from the lesion for confirmation of HSV-1 positivity.
Patients not developing 3 lesions with an HSV lesion score 3-7 during the 9 months observation phase are considered screening failures and will not be randomised into the treatment part of the trial.
Randomised, double-blind treatment phase (12 months):
This phase consists of four scheduled visits (day 30/120/240/365) and unscheduled visits for treatment of lesion 3 and 4, respectively.
Patients who have developed 3 outbreaks within the observational phase will enter the treatment phase. The third of these lesions will already be treated. Notably, patients do not have to complete the 9 months observation phase if they develop the 3rd lesion earlier - treatment starts with occurrence of a 3rd lesion.
With the occurrence of lesion 3 within the 9 months observation phase, patients need to schedule a visit at the study site when a vesicle is present. If the patient meets all inclusion criteria, randomisation takes place. An electronic patient reported outcome (ePRO) tool will be installed on the patients' devices and questionnaires will be answered. The lesion will be documented in the ePRO app with a photo. A swab of the lesion will be taken which preferably should contain fluid from the vesicular lesion. Subsequently, blinded IMP will be applied to the lesion. The investigator will determine the lesion start and end date based on information provided by the patient. 3 additional vials of study IMP for further treatment of this lesion will be handed over to the patient for self-application.
Upon occurrence of a fourth lesion in the treatment phase, the same procedure will be repeated at another unscheduled visit at the site when a vesicle is present. Again, IMP will be handed over to the patient for further treatment of this lesion.
All subsequent lesions occurring during the 12 months treatment phase need to be documented by the patient by photos and questionnaires. At each lesion episode, single swabs will be taken, but no further IMP will be applied and no unscheduled visit is necessary, but phone calls. The investigator will assess and medically confirm the lesion to be herpes-related and will determine the lesion start and end date based on information and photos provided by the patient and patient entries in the ePRO. Standard-of-care treatment (SoC) can optionally be applied.
Treatments and Examinations during the Study:
During all phases of the trial, patients need to report disease-specific symptoms and outbreak impact upon recognition of first symptoms during the study.
Orolabial viral shedding of patients is assessed by quantitative real time polymerase chain reaction (qRT-PCR) derived from swabs. These will be taken daily for 28 days in the orolabial region during the 9 months observation period starting after lesion 2, at occurrence of lesion 3 at visit 3 and 4 months after randomisation (starting at visit 5), respectively.
Each lesion recurrence has to be documented by the patient in the patient eDiary. In case of development of new lesions after lesion 3 or 4, patients will be instructed to take a swab of the lesion and provide this to the site for HSV-1 PCR outbreak confirmation. The patients must take photos (preferably daily) of the lesion until healing. These photos will be transferred to the sites' source data. The investigator will assess and medically confirm the lesion to be herpes-related and will determine the lesion start and end date based on information and photos provided by the patient and patient entries in the electronic diary.
Lesions will be rated according to a lesion score. For every lesion episode (outbreak), patients will be asked to report disease specific symptoms and outbreak impact in electronic questionnaires on a daily basis, from recognition of first symptoms until complete resolution of the symptoms.
Post-trial follow-up phase (12 months):
After the treatment phase, patients are further followed-up by phone every 3 months for a total duration of additional 12 months.
- Conditions
- Herpes Labialis
- Being tested
- HDIT101 (blinded therapy), Placebo (blinded therapy), Photo documentation of orolabial herpes lesions, Completion of questionnaires (patient-reported outcomes), 28-day swabbing of orolabial region
- Keywords
- Herpes simplex virus 1
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDIT101 (blinded therapy)Drug
Patients will be treated with with topical HDIT101 (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase.
Placebo (blinded therapy)Drug
Patients will be treated with with topical placebo (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase.
Photo documentation of orolabial herpes lesionsBehavioural
Patients will be asked to document their orolabial lesions with photos by using their smart phone
Completion of questionnaires (patient-reported outcomes)Behavioural
Patients will be asked to document their health status in questionnaires by using their smart phone
28-day swabbing of orolabial regionProcedure or surgery
Patients will be asked to complete 3 episodes of 28-day swabbing of orolabial lesions
Blood drawingsProcedure or surgery
Blood will be drawn for e.g. safety lab, HSV-analysis, pharmacokinetic etc.
| Study group | Role | What they receive |
|---|---|---|
| HDIT101 | Experimental | Topical application of HDIT101 solution to orolabial herpes lesion (4 times over 2 days). Blinded study drug will be applied to 2 lesions in the study Receives: Drug: HDIT101 (blinded therapy); Behavioral: Photo documentation of orolabial herpes lesions; Behavioral: Completion of questionnaires (patient-reported outcomes); Procedure: 28-day swabbing of orolabial region; Procedure: Blood drawings |
| Placebo to HDIT101 | Placebo comparator | Topical application of placebo solution to orolabial herpes lesion (4 times over 2 days). Blinded study drug will be applied to 2 lesions in the study Receives: Drug: Placebo (blinded therapy); Behavioral: Photo documentation of orolabial herpes lesions; Behavioral: Completion of questionnaires (patient-reported outcomes); Procedure: 28-day swabbing of orolabial region; Procedure: Blood drawings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: Number of recurrences after topical HDIT101 versus placebo after 12 months.
The recurrence rate is defined as number of recurrences in the 12 months treatment phase divided by the total number of study days (in the 12 months treatment phase) after first IMP treatment
Measured: During 12 months treatment phase
Secondary outcomes (4)
Percentage of days with a lesion
Percentage of days with a lesion
Measured: During 12 months treatment phase
Duration of recurrent lesions
Duration of recurrent lesions
Measured: During 12 months treatment phase
Time to first recurrence
Time to first recurrence reported by the patient and verified by the investigator (If no further lesion develops, time to end of study is taken).
Measured: During 12 months treatment phase
Number of aborted lesions
An aborted lesion is a non-ulcerative lesion that does not progress beyond the papule stage
Measured: During 12 months treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start8 Oct 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: stopped for futility in interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies 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
- Model description
- Randomized, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg ImmunoTherapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539483
- Sponsor's protocol ID
- HTX101-03L
- Acronym
- MATCH-1
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2020
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind Phase II Trial of Topical HDIT101 Versus Placebo in Patients With Chronic Recurrent HSV-1 Infection and Orolabial Lesion
- ClinicalTrials.gov ID
- NCT04539483
- Acronym / sponsor ID
- MATCH-1 / HTX101-03L
- Conditions
- Herpes Labialis
- Keywords
- Herpes simplex virus 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: stopped for futility in interim analysis
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Heidelberg ImmunoTherapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 7 Sep 2020 (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.
This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo. HSV-1-positive patients with at least 6 orolabial herpes lesions in the last 12 months can be included.
The patients need to present with 3 herpes lesions within a 9 months observation phase. With the occurrence of the third lesion, the patients will enter the 12 months treatment phase and will be randomized in a 2:1 ratio to topical HDIT or placebo applied over 2 days. A potential fourth lesion will also be treated with the blinded study medication and additional lesions will be documented.
In a 12 months post-trial follow-up phase, further information on the occurence of lesions will be collected 4 times by phone.
Study duration per patient will be up to 21 months plus 12 months post-trial follow-up by phone. Patients need to come for study visits up to 9 times.
Detailed description
This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo.
Approximately 138 eligible patients will be randomised at a ratio of 2:1 to topical HDIT or corresponding placebo.
The trial consists of 3 parts: An observation phase (up to 9 months), a treatment phase of 12 months, and a post-trial follow-up phase of additional 12 months: The observation phase ensures that the patient develops a minimum number of lesions during the trial. In the 12 months treatment phase, blinded study treatment consisting of topical HDIT101 or placebo is applied to the patients at the first and second lesion episode. After completion of the treatment phase, patients are followed for additional 12 months for assessment of the development of further lesions (post-trial follow-up phase).
Observation phase (max. 9 months):
Eligible patients suffering from chronic recurrent herpes orolabialis for at least 12 months and reporting ≥ 6 lesions in the last 12 months can enter the observation phase. This part of the study serves for confirmation that patients develop a minimum number of 3 lesions within the 9 months observation period. No study treatment is applied in the observation phase, but standard-of-care treatment (SoC) can optionally be applied. Single swabs should additionally be taken from the lesion for confirmation of HSV-1 positivity.
Patients not developing 3 lesions with an HSV lesion score 3-7 during the 9 months observation phase are considered screening failures and will not be randomised into the treatment part of the trial.
Randomised, double-blind treatment phase (12 months):
This phase consists of four scheduled visits (day 30/120/240/365) and unscheduled visits for treatment of lesion 3 and 4, respectively.
Patients who have developed 3 outbreaks within the observational phase will enter the treatment phase. The third of these lesions will already be treated. Notably, patients do not have to complete the 9 months observation phase if they develop the 3rd lesion earlier - treatment starts with occurrence of a 3rd lesion.
With the occurrence of lesion 3 within the 9 months observation phase, patients need to schedule a visit at the study site when a vesicle is present. If the patient meets all inclusion criteria, randomisation takes place. An electronic patient reported outcome (ePRO) tool will be installed on the patients' devices and questionnaires will be answered. The lesion will be documented in the ePRO app with a photo. A swab of the lesion will be taken which preferably should contain fluid from the vesicular lesion. Subsequently, blinded IMP will be applied to the lesion. The investigator will determine the lesion start and end date based on information provided by the patient. 3 additional vials of study IMP for further treatment of this lesion will be handed over to the patient for self-application.
Upon occurrence of a fourth lesion in the treatment phase, the same procedure will be repeated at another unscheduled visit at the site when a vesicle is present. Again, IMP will be handed over to the patient for further treatment of this lesion.
All subsequent lesions occurring during the 12 months treatment phase need to be documented by the patient by photos and questionnaires. At each lesion episode, single swabs will be taken, but no further IMP will be applied and no unscheduled visit is necessary, but phone calls. The investigator will assess and medically confirm the lesion to be herpes-related and will determine the lesion start and end date based on information and photos provided by the patient and patient entries in the ePRO. Standard-of-care treatment (SoC) can optionally be applied.
Treatments and Examinations during the Study:
During all phases of the trial, patients need to report disease-specific symptoms and outbreak impact upon recognition of first symptoms during the study.
Orolabial viral shedding of patients is assessed by quantitative real time polymerase chain reaction (qRT-PCR) derived from swabs. These will be taken daily for 28 days in the orolabial region during the 9 months observation period starting after lesion 2, at occurrence of lesion 3 at visit 3 and 4 months after randomisation (starting at visit 5), respectively.
Each lesion recurrence has to be documented by the patient in the patient eDiary. In case of development of new lesions after lesion 3 or 4, patients will be instructed to take a swab of the lesion and provide this to the site for HSV-1 PCR outbreak confirmation. The patients must take photos (preferably daily) of the lesion until healing. These photos will be transferred to the sites' source data. The investigator will assess and medically confirm the lesion to be herpes-related and will determine the lesion start and end date based on information and photos provided by the patient and patient entries in the electronic diary.
Lesions will be rated according to a lesion score. For every lesion episode (outbreak), patients will be asked to report disease specific symptoms and outbreak impact in electronic questionnaires on a daily basis, from recognition of first symptoms until complete resolution of the symptoms.
Post-trial follow-up phase (12 months):
After the treatment phase, patients are further followed-up by phone every 3 months for a total duration of additional 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind
| Arm | Type | Receives |
|---|---|---|
| HDIT101 | Experimental | Drug: HDIT101 (blinded therapy), Behavioral: Photo documentation of orolabial herpes lesions, Behavioral: Completion of questionnaires (patient-reported outcomes), Procedure: 28-day swabbing of orolabial region, Procedure: Blood drawingsTopical application of HDIT101 solution to orolabial herpes lesion (4 times over 2 days). Blinded study drug will be applied to 2 lesions in the study |
| Placebo to HDIT101 | Placebo comparator | Drug: Placebo (blinded therapy), Behavioral: Photo documentation of orolabial herpes lesions, Behavioral: Completion of questionnaires (patient-reported outcomes), Procedure: 28-day swabbing of orolabial region, Procedure: Blood drawingsTopical application of placebo solution to orolabial herpes lesion (4 times over 2 days). Blinded study drug will be applied to 2 lesions in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HDIT101 (blinded therapy)Patients will be treated with with topical HDIT101 (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase. | Drug | HDIT101 |
| Placebo (blinded therapy)Patients will be treated with with topical placebo (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase. | Drug | Placebo to HDIT101 |
| Photo documentation of orolabial herpes lesionsPatients will be asked to document their orolabial lesions with photos by using their smart phone | Behavioural | HDIT101, Placebo to HDIT101 |
| Completion of questionnaires (patient-reported outcomes)Patients will be asked to document their health status in questionnaires by using their smart phone | Behavioural | HDIT101, Placebo to HDIT101 |
| 28-day swabbing of orolabial regionPatients will be asked to complete 3 episodes of 28-day swabbing of orolabial lesions | Procedure or surgery | HDIT101, Placebo to HDIT101 |
| Blood drawingsBlood will be drawn for e.g. safety lab, HSV-analysis, pharmacokinetic etc. | Procedure or surgery | HDIT101, Placebo to HDIT101 |
Primary outcome
Primary endpoint: Number of recurrences after topical HDIT101 versus placebo after 12 months.
Time frame: During 12 months treatment phase
The recurrence rate is defined as number of recurrences in the 12 months treatment phase divided by the total number of study days (in the 12 months treatment phase) after first IMP treatment
4 secondary outcomes
Percentage of days with a lesion
Time frame: During 12 months treatment phase
Duration of recurrent lesions
Time frame: During 12 months treatment phase
Time to first recurrence
Time frame: During 12 months treatment phase
Number of aborted lesions
Time frame: During 12 months treatment phase
Results and safety
The study was stopped early (reason given: stopped for futility in interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Herpes Labialis
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Anogenital Herpes, COVID-19
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.
5 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 HDIT101 (blinded therapy), Photo documentation of orolabial herpes lesions and Completion of questionnaires (patient-reported outcomes) in people with Herpes Labialis, run by Heidelberg ImmunoTherapeutics GmbH at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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 was stopped early (reason given: stopped for futility in interim analysis). Results are not available in the source record.
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?
Primary endpoint: Number of recurrences after topical HDIT101 versus placebo after 12 months. (time frame: During 12 months treatment phase). 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 25 Sep 2023.