Psoriasis VulgarisPhase 2NCT00875277
A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
A Phase 2 study testing LEO 29102 cream, Betamethasone Dipropionate Cream and LEO 29102 Plus Calcipotriol Cream in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
Trial summary
The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 29102 cream, Betamethasone Dipropionate Cream and LEO 29102 Plus Calcipotriol Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects having understood and signed an informed consent form
- All skin types
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
- Subjects willing and able to follow all the study procedures and complete the whole study
- Subjects affiliated to social security system
Who cannot join
- Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
- Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
- Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy
- Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
- Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris
The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 29102 cream, LEO 29102 Cream Vehicle, Betamethasone Dipropionate Cream, LEO 29102 Plus Calcipotriol Cream, LEO 29102 Plus Betamethasone Dipropionate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 29102 creamDrug
LEO 29102 Cream VehicleDrug
Betamethasone Dipropionate CreamDrug
LEO 29102 Plus Calcipotriol CreamDrug
LEO 29102 Plus Betamethasone DipropionateDrug
Daivobet® OintmentDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 29102 cream | Experimental | LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks Receives: Drug: LEO 29102 cream |
| LEO 29102 Cream Vehicle | Placebo comparator | LEO 29102 cream vehicle applied topically twice daily for 4 weeks. Receives: Drug: LEO 29102 Cream Vehicle |
| Betamethasone Dipropionate Cream | Experimental | Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. Receives: Drug: Betamethasone Dipropionate Cream |
| LEO 29102 Plus Calcipotriol Cream | Experimental | LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks. Receives: Drug: LEO 29102 Plus Calcipotriol Cream |
| LEO 29102 Plus Betamethasone Dipropionate | Experimental | LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. Receives: Drug: LEO 29102 Plus Betamethasone Dipropionate |
| Daivobet® Ointment | Active comparator | Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks. Receives: Drug: Daivobet® Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
The (sub)investigator made the following clinical assessments by use of the scale below:
Score; Intensity; Description
Erythema:
0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red
Scaling:
0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales
Infiltration:
0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration
The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
Measured: From baseline (Day 1) to end of treatment (Day 29)
Secondary outcomes (12)
Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
The (sub)investigator made the following clinical assessments by use of the scale below:
Score; Intensity; Description
Erythema:
0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red
Scaling:
0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales
Infiltration:
0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
Measured: From baseline (Day 1) to end of treatment (Day 29)
Change in Erythema Compared to Baseline
The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.
The (sub)investigator made the following clinical assessments by use of the scale below:
Score; Intensity; Description
Erythema:
0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red
Measured: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25
Change in Scaling Compared to Baseline
The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.
The (sub)investigator made the following clinical assessments by use of the scale below:
Score; Intensity; Description
Scaling:
0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales
Measured: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Change in Infiltration Compared to Baseline
The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.
The (sub)investigator made the following clinical assessments by use of the scale below:
Score; Intensity; Description
Infiltration:
0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration
Measured: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
The (sub)investigator made the following clinical assessments by use of the scale below:
Score; Intensity; Description
Erythema:
0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red
Scaling:
0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales
Infiltration:
0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration
The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
Measured: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment.
Measured: At Day 8, Day 15, Day 22 and end of treatment
Biomarkers by Immunochemistry
3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.
Cells counted per mm^2 were cells that were positive for the indicated biomarker.
Measured: At end of treatment
Biomarkers by Immunochemistry: Epidermal Differentiation
3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.
Measured: At end of treatment
Biomarkers by Immunochemistry: Epidermal Proliferation
3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.
By measurement of the cell-cycle marker, Ki-67 protein, an evaluation of the degree of skin cell proliferation and thereby epidermal proliferation could be obtained. Cells counted per mm^2 were cells that were positive for the indicated biomarker.
Measured: At end of treatment
Pathology and Histology by Treatment
Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. The extent of the following parameters were measured in scored semi-quantitatively (semi) on blinded haematoxylin and eosin (HE) sections. Semi-quantitative scoring was categorized as No (0), mild (1), moderate (2), marked (3) or severe (4). In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum) the tissue was classified by the characteristics seen below:
- Morphology of epidermis
- Stratum corneum (semi (extent of))
- Stratum granulosum (semi (extent of))
- Parakeratosis (semi (extent of))
- Infiltration of inflammatory cells (semi (extent of))
Measured: At end of treatment
Pathology and Histology by Treatment: Epidermal Thickness
Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic epidermal thickness. This was measured in the absolute number of µm measured on blinded haematoxylin and eosin (HE) sections..
Measured: At end of treatment
Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses
Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study.
In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic of frequency of neutrophil microabscesses (Monroe´s abscess). This was measured in absolute number of cells that were positive for the marker on blinded haematoxylin and eosin (HE) sections.
Measured: At end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriasis VulgarisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, International Clinical Development, MD, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875277
- Sponsor's protocol ID
- PLQ-003
- Status last verified
- Aug 2018
- First submitted
- 2 Apr 2009
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT00875277
- Acronym / sponsor ID
- PLQ-003
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 11 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LEO 29102 cream | Experimental | Drug: LEO 29102 creamLEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks |
| LEO 29102 Cream Vehicle | Placebo comparator | Drug: LEO 29102 Cream VehicleLEO 29102 cream vehicle applied topically twice daily for 4 weeks. |
| Betamethasone Dipropionate Cream | Experimental | Drug: Betamethasone Dipropionate CreamBetamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. |
| LEO 29102 Plus Calcipotriol Cream | Experimental | Drug: LEO 29102 Plus Calcipotriol CreamLEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks. |
| LEO 29102 Plus Betamethasone Dipropionate | Experimental | Drug: LEO 29102 Plus Betamethasone DipropionateLEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. |
| Daivobet® Ointment | Active comparator | Drug: Daivobet® OintmentDaivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects having understood and signed an informed consent form
- All skin types
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
- Subjects willing and able to follow all the study procedures and complete the whole study
- Subjects affiliated to social security system
Key exclusion criteria (6 listed)
- Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
- Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
- Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy
- Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
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 |
|---|---|---|
| LEO 29102 cream | Drug | LEO 29102 cream |
| LEO 29102 Cream Vehicle | Drug | LEO 29102 Cream Vehicle |
| Betamethasone Dipropionate Cream | Drug | Betamethasone Dipropionate Cream |
| LEO 29102 Plus Calcipotriol Cream | Drug | LEO 29102 Plus Calcipotriol Cream |
| LEO 29102 Plus Betamethasone Dipropionate | Drug | LEO 29102 Plus Betamethasone Dipropionate |
| Daivobet® Ointment | Drug | Daivobet® Ointment |
Primary outcome
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
Time frame: From baseline (Day 1) to end of treatment (Day 29)
The (sub)investigator made the following clinical assessments by use of the scale below: Score; Intensity; Description Erythema: 0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red Scaling: 0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales Infiltration: 0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).
12 secondary outcomes
Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
Time frame: From baseline (Day 1) to end of treatment (Day 29)
Change in Erythema Compared to Baseline
Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25
Change in Scaling Compared to Baseline
Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Change in Infiltration Compared to Baseline
Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
Time frame: At Day 8, Day 15, Day 22 and end of treatment
Biomarkers by Immunochemistry
Time frame: At end of treatment
Biomarkers by Immunochemistry: Epidermal Differentiation
Time frame: At end of treatment
Biomarkers by Immunochemistry: Epidermal Proliferation
Time frame: At end of treatment
Pathology and Histology by Treatment
Time frame: At end of treatment
Pathology and Histology by Treatment: Epidermal Thickness
Time frame: At end of treatment
Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses
Time frame: At end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Director, International Clinical Development, MD study director
LEO Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 29102 cream, Betamethasone Dipropionate Cream and LEO 29102 Plus Calcipotriol Cream in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
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 5 inclusion and 6 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 12 Mar 2025. 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 France. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) (time frame: From baseline (Day 1) to end of treatment (Day 29)). 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 12 Mar 2025.