PsoriasisPhase 1NCT05428202
Phase I Study of GN-037 Cream for Psoriasis
A Phase 1 study testing GN037 in people with Psoriasis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be administered to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- GN037
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2022to 30 Sep 2022
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female healthy volunteers aged 18-65 years*
- Volunteers who were informed about participation in the study and agreed to give their written informed consent.
- Volunteers with negative qPCR SARS-CoV-2 result in nasopharyngeal or sputum samples
- Volunteers in good general health (without any known disease in the history and physical examination in the 14 days before participating in the study)
- Volunteers with negative HIV, Hepatitis B and C tests
- Volunteers with negative alcohol breath test
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- Volunteers with negative urine addictive drug screening test (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate)
- Volunteers who agreed not to be exposed to the direct sun light during the study
- Female volunteers of childbearing potential must have a negative pregnancy test at the screening visit and must agree to use an effective method of contraception throughout the study
- Volunteers who can comply with all scheduled visits, laboratory tests and other study procedures * The principal investigator will take the necessary measures to ensure that the representation
- Male and female patients aged 18-65 years*
- Patients who were informed about participation in the study and agreed to give their written informed consent.
- Patients with negative qPCR SARS-CoV-2 result in nasopharynx or sputum samples
- Patients diagnosed with plaque psoriasis by a dermatologist at least 6 months before inclusion in the study
- Patients whose lesions are less than 5% of the body surface area (BSA)
- Patients who did not receive local or systemic treatment for plaque psoriasis, or who received the last psoriasis treatment 28 days or more before
- Patients who are confirmed to be healthy by medical history and physical examination and who do not have any clinically significant disease/condition other than plaque psoriasis that could affect the study evaluation.
- Patients with disease severity with Physician's Global Assessment (IGA) score ≥3 (moderate) as an overall assessment of all lesions to be treated
- Patients with negative HIV, Hepatitis B and C tests
- Patients with negative alcohol breath test
- Patients with negative urine addictive drug screening test (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate)
- Patients who agreed not to be exposed to the sun during the study
- Female patients of childbearing potential must have a negative pregnancy test at the screening visit and must agree to use an effective method of contraception throughout the study
- Patients who can comply with all scheduled visits, laboratory tests, and other study procedures * The principal investigator will take the necessary measures to ensure that the representation of females and males is equal.
Who cannot join
- Subjects with known hypersensitivity to any component of the study drug
- Female volunteers who are pregnant or breastfeeding or have a positive pregnancy test
- Volunteers with a history of chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the screening visit
- Patients with skin atrophy, pigmentation or extensive scarring that would preclude study evaluation at targeted treatment sites
- Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the investigator's opinion, may affect study evaluations at targeted treatment sites
- Volunteers using moisturizing or skin softening ointment/lotion/cream on their intended treatment site within 3 days prior to enrollment in the study.
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- Volunteers who cannot come to the study center for follow-up visits
- Volunteers taking part in another clinical study concurrently
- Volunteers with positive urine addictive drug screening test and/or alcohol test
- Patients with known hypersensitivity to any component of the study drug
- Pregnant or lactating or female patients with a positive pregnancy test
- Patients who require any other medication (topical or systemic) that may affect the course of the disease during the study period (eg antibiotics, antihistamines)
- Patients with a history of chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the screening visit
- Patients with skin atrophy, pigmentation, or extensive scarring that would preclude evaluation of study drug efficacy at targeted treatment sites
- Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the investigator's opinion, may affect study evaluations at targeted treatment sites
- Patients diagnosed with pustular, guttate, inverse, exfoliative or erythrodermic psoriasis at targeted treatment sites
- Patients with a history of psoriasis unresponsive to topical treatments
- Patients who used moisturizer or skin softening ointment/lotion/cream to the intended treatment areas within 3 days prior to enrolling in the study.
- Patients who cannot come to the study center for follow-up visits
- Patients taking part in another clinical study concurrently
- Patients with positive urine addictive drug screening test and/or alcohol test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Assess Safety, Tolerability and Clinical Benefits of Topically Applied GN-037 Cream in Healthy Volunteers and Patients Diagnosed With Psoriasis
In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be administered to healthy volunteers. In the active dose arm, 4 healthy volunteers will receive GN-037 cream and 2 healthy volunteers will receive placebo. Randomization in each dose arm will be 2:1.
Read the detailed description
In this single-center, randomized, double-blind, placebo-controlled, and two-stage Phase I study, it was planned to evaluate the safety, tolerability and clinical efficacy of topically applied GN-037 cream in healthy volunteers and patients diagnosed with plaque psoriasis.
In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be administered to healthy volunteers. In the active dose arm, 4 healthy volunteers will receive GN-037 cream and 2 healthy volunteers will receive placebo. Randomization in each dose arm will be 2:1.
The study will be performed in two stages; healthy volunteers and patients. After consenting procedures, all subjects will be evaluated for their eligibility for the study. An electronic case report form (e-CRF) specially designed for this study will be used to record the data of the screened volunteers. This e-CRF will assign a volunteer number to each volunteer, as well as providing randomization.
During the screening visit (day 0), a swab for the real-time RT-PCR COVID-19 test will be obtained from all subjects before hospitalization who met the study criteria and gave informed voluntary consent, following the physical examination and screening tests, the volunteers will be interned at the clinic for overnight observation. Hospitalization will be carried out for app 24 hours.
In the healthy subject section of the study, GN-037 cream containing urea, salicylic acid, retinoic acid and clobetasol 17-propionate and matching placebo will be applied to 18 healthy volunteers and will be tested as low dose, medium dose and high dose according to the surface area to be applied in the selected target area. A placebo will be administered to a total of 6 healthy volunteers. All applications will be performed by the investigators during the initial application period and subjects will continue applications as instructed.
GN-037 cream and placebo application will be divided into different stages according to the dose groups specified below, and all volunteers will not be applied on the same day. The study will first start with the administration of low dose GN-037 cream and placebo and will continue through increasing the dosage, hence the applied surface area
- Low dose: 6 healthy volunteers in an area of 5 cm2 in the knee and/or elbow area.
- Medium dose: 6 healthy volunteers on an area of 15 cm2 in the knee and/or elbow area.
- High dose: 6 healthy volunteers will be applied a thin film of GN-037 cream or placebo to an area of 30 cm2 in the knee and/or elbow region, twice a day, morning and evening, for 14 days.
Placebo product will resemble the active products in weight, color and texture.
6 healthy volunteers who were admitted to the clinic at the screening visit will be randomized 2:1 to the low-dose GN-037 cream (n=4) or low-dose placebo (n=2) arm on day 1 of the study. Volunteers in the low dose group will be evaluated for safety data on day 10. If these safety results are found to be appropriate, 6 more healthy volunteers will be recruited for medium dose administration and will be randomized in a 2:1 ratio, with 4 volunteers assigned to the GN-037 cream arm and 2 volunteers to the placebo arm. After safety assessment high dose administration will be initiated. High dose group, will be randomized at a ratio of 2:1; as active:placebo and after final safety evaluation patients with plaque psoriasis (n=6) will be included in the study. All inclusion and efficacy/safety evaluations will be performed by a dermatologist.
All subjects will be treated for 14 days (active and placebo) and a final safety evaluation will be performed on day 19. Study drugs will be collected on this visit and the cream usage will be measured by weighing the used cream tubes. On day 28, a telephone visit will be performed for final safety evaluation.
- Conditions
- Psoriasis
- Being tested
- GN037, Placebo
- Keywords
- Psoriasis, Phase 1 Study, Healthy Volunteers, Patients, Investigational Drug
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GN037Drug
Also called Active
GN-037 cream containing urea, salicylic acid, retinoic acid and clobetasol 17-propionate and matching placebo
PlaceboDrug
Also called Placebo Cream
Placebo cream containing base without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| GN 037 cream | Experimental | Healthy volunteers will receive GN037 cream in 2 to 1 ration
Application will be done twice daily, to selected area of body on the fore arm:
Increasing dosages of dosages: Low dose to a 5 cm2 skin area, Medium dose to15 cm2 skin area, High dose to 30 cm2 skin area
Psoriatic patients will receive GN037 cream Aplication twice daily, to a selected body target lesion High dose 30 cm2 Receives: Drug: GN037 |
| Placebo Cream | Placebo comparator | Placebo cream will be applied in 2 to 1 ratio twice daily, to selected area of fore arm.
Low dose to 5 cm2 skin area, Medium dose 15 cm2 skin area, High dose 30 cm2 skin area Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Adverse Events and Serious Adverse Events.
Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).
Measured: 28 days
Secondary outcomes (4)
Percent Change From Baseline in Total Plaque Severity Score in Psoriasis Patients From baseline at days 6 and 14 with GN-037 cream application.
Difference in least squares mean percent change from baseline at days 6 and 14 in total plaque severity score (TPSS) with GN-037 cream application. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. A negative percent change indicates better outcome.
Measured: 19 days
Percent Change From Baseline in Target Plaque Area in Psoriasis Patients From baseline at days 6 and 14 with GN-037 cream application. [ Time Frame: 19 days ]
Difference in least squares mean percent change from baseline at days 6 and 14 in target plaque area (TPA) with GN-037 cream application. Target plaque area (cm2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates mild disease
Measured: 19 days
Difference in Psoriasis Area Severity Index (PASI) From baseline at days 6 and 14 with GN-037 cream application.
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Measured: 19 days
Change in Physician Global Assessment (PGA) score From Baseline achieved at days 6 and 14 with GN-037 cream application.
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis at a given timepoint. It is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start28 Mar 2022
- Primary completion28 Apr 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- Monitor CRO
- Responsible party
- Principal investigator, Zafer SEZER, TC Erciyes University
- Investigators
- Oğuz Akbaş, MD, Study director, Monitor CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428202
- Sponsor's protocol ID
- MON839.151.5
- Status last verified
- Jun 2023
- First submitted
- 20 May 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sezer Z, Inal A, Cinar SL, Mazicioglu MM, Altug S, Karasulu HY, Diril M, Mehmetoglu Al A, Kozlu S, Ulu N. Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial. Dermatol Ther (Heidelb). 2023 Jul;13(7):1489-1501. doi: 10.1007/s13555-023-00939-7. Epub 2023 Jun 10.
PubMed 37300792
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Assess Safety, Tolerability and Clinical Benefits of Topically Applied GN-037 Cream in Healthy Volunteers and Patients Diagnosed With Psoriasis
- ClinicalTrials.gov ID
- NCT05428202
- Acronym / sponsor ID
- MON839.151.5
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Phase 1 Study, Healthy Volunteers, Patients, Investigational Drug
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- Monitor CRO
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 23 Jun 2022 (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.
In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be administered to healthy volunteers. In the active dose arm, 4 healthy volunteers will receive GN-037 cream and 2 healthy volunteers will receive placebo. Randomization in each dose arm will be 2:1.
Detailed description
In this single-center, randomized, double-blind, placebo-controlled, and two-stage Phase I study, it was planned to evaluate the safety, tolerability and clinical efficacy of topically applied GN-037 cream in healthy volunteers and patients diagnosed with plaque psoriasis.
In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be administered to healthy volunteers. In the active dose arm, 4 healthy volunteers will receive GN-037 cream and 2 healthy volunteers will receive placebo. Randomization in each dose arm will be 2:1.
The study will be performed in two stages; healthy volunteers and patients. After consenting procedures, all subjects will be evaluated for their eligibility for the study. An electronic case report form (e-CRF) specially designed for this study will be used to record the data of the screened volunteers. This e-CRF will assign a volunteer number to each volunteer, as well as providing randomization.
During the screening visit (day 0), a swab for the real-time RT-PCR COVID-19 test will be obtained from all subjects before hospitalization who met the study criteria and gave informed voluntary consent, following the physical examination and screening tests, the volunteers will be interned at the clinic for overnight observation. Hospitalization will be carried out for app 24 hours.
In the healthy subject section of the study, GN-037 cream containing urea, salicylic acid, retinoic acid and clobetasol 17-propionate and matching placebo will be applied to 18 healthy volunteers and will be tested as low dose, medium dose and high dose according to the surface area to be applied in the selected target area. A placebo will be administered to a total of 6 healthy volunteers. All applications will be performed by the investigators during the initial application period and subjects will continue applications as instructed.
GN-037 cream and placebo application will be divided into different stages according to the dose groups specified below, and all volunteers will not be applied on the same day. The study will first start with the administration of low dose GN-037 cream and placebo and will continue through increasing the dosage, hence the applied surface area
- Low dose: 6 healthy volunteers in an area of 5 cm2 in the knee and/or elbow area.
- Medium dose: 6 healthy volunteers on an area of 15 cm2 in the knee and/or elbow area.
- High dose: 6 healthy volunteers will be applied a thin film of GN-037 cream or placebo to an area of 30 cm2 in the knee and/or elbow region, twice a day, morning and evening, for 14 days.
Placebo product will resemble the active products in weight, color and texture.
6 healthy volunteers who were admitted to the clinic at the screening visit will be randomized 2:1 to the low-dose GN-037 cream (n=4) or low-dose placebo (n=2) arm on day 1 of the study. Volunteers in the low dose group will be evaluated for safety data on day 10. If these safety results are found to be appropriate, 6 more healthy volunteers will be recruited for medium dose administration and will be randomized in a 2:1 ratio, with 4 volunteers assigned to the GN-037 cream arm and 2 volunteers to the placebo arm. After safety assessment high dose administration will be initiated. High dose group, will be randomized at a ratio of 2:1; as active:placebo and after final safety evaluation patients with plaque psoriasis (n=6) will be included in the study. All inclusion and efficacy/safety evaluations will be performed by a dermatologist.
All subjects will be treated for 14 days (active and placebo) and a final safety evaluation will be performed on day 19. Study drugs will be collected on this visit and the cream usage will be measured by weighing the used cream tubes. On day 28, a telephone visit will be performed for final safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| GN 037 cream | Experimental | Drug: GN037Healthy volunteers will receive GN037 cream in 2 to 1 ration Application will be done twice daily, to selected area of body on the fore arm: Increasing dosages of dosages: Low dose to a 5 cm2 skin area, Medium dose to15 cm2 skin area, High dose to 30 cm2 skin area Psoriatic patients will receive GN037 cream Aplication twice daily, to a selected body target lesion High dose 30 cm2 |
| Placebo Cream | Placebo comparator | Drug: PlaceboPlacebo cream will be applied in 2 to 1 ratio twice daily, to selected area of fore arm. Low dose to 5 cm2 skin area, Medium dose 15 cm2 skin area, High dose 30 cm2 skin area |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male and female healthy volunteers aged 18-65 years*
- Volunteers who were informed about participation in the study and agreed to give their written informed consent.
- Volunteers with negative qPCR SARS-CoV-2 result in nasopharyngeal or sputum samples
- Volunteers in good general health (without any known disease in the history and physical examination in the 14 days before participating in the study)
- Volunteers with negative HIV, Hepatitis B and C tests
Key exclusion criteria (21 listed)
- Subjects with known hypersensitivity to any component of the study drug
- Female volunteers who are pregnant or breastfeeding or have a positive pregnancy test
- Volunteers with a history of chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the screening visit
- Patients with skin atrophy, pigmentation or extensive scarring that would preclude study evaluation at targeted treatment sites
- Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the investigator's opinion, may affect study evaluations at targeted treatment sites
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 |
|---|---|---|
| GN037Also: ActiveGN-037 cream containing urea, salicylic acid, retinoic acid and clobetasol 17-propionate and matching placebo | Drug | GN 037 cream |
| PlaceboAlso: Placebo CreamPlacebo cream containing base without active ingredients | Drug | Placebo Cream |
Primary outcome
Severity of Adverse Events and Serious Adverse Events.
Time frame: 28 days
Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).
4 secondary outcomes
Percent Change From Baseline in Total Plaque Severity Score in Psoriasis Patients From baseline at days 6 and 14 with GN-037 cream application.
Time frame: 19 days
Percent Change From Baseline in Target Plaque Area in Psoriasis Patients From baseline at days 6 and 14 with GN-037 cream application. [ Time Frame: 19 days ]
Time frame: 19 days
Difference in Psoriasis Area Severity Index (PASI) From baseline at days 6 and 14 with GN-037 cream application.
Time frame: 19 days
Change in Physician Global Assessment (PGA) score From Baseline achieved at days 6 and 14 with GN-037 cream application.
Time frame: 19 days
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 13 Jun 2023.
- Derived from this study: PubMed 37300792Sezer Z, Inal A, Cinar SL, Mazicioglu MM, Altug S, Karasulu HY, Diril M, Mehmetoglu Al A, Kozlu S, Ulu N. Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial. Dermatol Ther (Heidelb). 2023 Jul;13(7):1489-1501. doi: 10.1007/s13555-023-00939-7. Epub 2023 Jun 10.
- 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.
Oğuz Akbaş, MD study director
Monitor CRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GN037 in people with Psoriasis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 24 inclusion and 21 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Severity of Adverse Events and Serious Adverse Events. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05428202, which also lists 1 linked publication.
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 13 Jun 2023.