Mild to Moderate Plaque PsoriasisPhase 3AKP01NCT05174598
A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis
A Phase 3 study testing Calcipotriol/AKVANO, 50 μg/g cutaneous solution and Calcipotriol Ointment 50 micrograms/g in people with Mild to Moderate Plaque Psoriasis, run by Cadila Pharnmaceuticals at 14 sites in India.
Trial summary
This study is a Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild to Moderate Plaque Psoriasis
- What is being tested?
- Calcipotriol/AKVANO, 50 μg/g cutaneous solution and Calcipotriol Ointment 50 micrograms/g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 14 sitesIndia
- Study dates
- 3 Oct 2018to 3 Dec 2020
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients (Non-pregnant) of plaque psoriasis aged 18 to 65 years having either Fitzpatrick skin type I-III or IV-VI.<br/>
- Diagnosis of stable plaque psoriasis for 6 month by a dermatologist with lesions on arms, legs or trunk.
- Mild to moderate psoriasis on Physician's global assessment (PGA),
- Body Surface Area (BSA) involvement of 5-10% (both included) and PASI ≥ 5.
- Patients must be willing to provide written informed consent and willing to comply with study requirements
Who cannot join
- Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
- Patient with any uncontrolled systemic disease
- Patient with positive serology tests like HIV, HCV \& HBsAg.
- Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
- Patient with spontaneously improving or rapidly deteriorating plaque psoriasis.
Show all 14Show fewer
- Use of systemic agents within four weeks prior to screening.
- Use of biologic agents within four weeks prior to study entry.
- Use of topical drugs that might alter the course of psoriasis or has received ultraviolet B treatment within two weeks prior to study entry.
- Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry.
- Known sensitivity to any of the study treatments and/or study treatment's components.
- Need for surgery or hospitalization during the study
- Pregnant or nursing Female patient or planning a pregnancy
- Concurrent involvement in any other clinical study within 30 days prior to entering the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
India14 sites
KLES Dr. Prabhakar Kore Hospital & Medical Reserach Centre
Belagavi, Karnataka, 590010
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
Government Medical College
Chhatrapati Sambhajinagar, Maharashtra, 431001
Kanoria Hospital & Research Centre
Gandhinagar, Gujarat, 382428
Downtown Hospital
Guwahati, Assam, 781006
Marwari Hospital & Research Centre
Guwahati, Assam, 781008
Midland Healthcare & Research Center
Lucknow, Uttar Pradesh, 226006
Gokuldas Tejpal Hospital Grant Government Medical College & Sir JJ Group of Hospital
Mumbai, Maharashtra, 400001
Dr. D.Y. Patil Hospital
Mumbai, Maharashtra, 400706
AC Subbareddy Government Hospital
Nellore, Andhra Pradesh, 524004
Sanjeevani CBCC USA Cancer Hospital
Raipur, Chhattisgarh, 492001
GMERS Medical College & Hospital
Vadodara, Gujarat, 390021
Dhiraj General Hospital
Vadodara, Gujarat, 391760
Surya Super Speciality Hospital
Varanasi, Uttar Pradesh, 221010
About this study
Official title: A Phase III, Multicentre, Randomized, Observer Blind, Parallel Group, Three Arms, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Topically Applied Calcipotriol/AKVANO 50 μg/g Cutaneous Solution Against Calcipotriol Ointment 50 Micrograms/g, Sandoz and Placebo in Patients With Mild to Moderate Plaque Psoriasis
This study is a Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to moderate plaque psoriasis
Read the detailed description
Total 278 patients with mild to moderate plaque psoriasis were randomized into the study. Study medications were applied twice daily for 8 weeks of study duration.
Patient's condition was assessed using of Physician's Global Assessment (PGA) and PASI Scale.
Primary objective of this study is to assess the therapeutic equivalence of Calcipotriol/AKVANO, 50 μg/g cutaneous solution with Calcipotriol Ointment 50 micrograms/g, Sandoz based on PASI score.
- Conditions
- Mild to Moderate Plaque Psoriasis
- Being tested
- Calcipotriol/AKVANO, 50 μg/g cutaneous solution, Calcipotriol Ointment 50 micrograms/g, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol/AKVANO, 50 μg/g cutaneous solutionDrug
Topical spray formulation containing Calcipotriol 50 μg/g. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
Calcipotriol Ointment 50 micrograms/gDrug
Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks.
PlaceboOther
Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriol/AKVANO, 50 μg/g cutaneous solution | Experimental | Spray formulation applied topically, twice daily, for the duration of 8 weeks. Receives: Drug: Calcipotriol/AKVANO, 50 μg/g cutaneous solution |
| Calcipotriol Ointment 50 micrograms/g, Sandoz | Active comparator | Ointment applied topically, twice daily, for the duration of 8 weeks. Receives: Drug: Calcipotriol Ointment 50 micrograms/g |
| Placebo | Placebo comparator | Spray formulation applied topically, twice daily, for the duration of 8 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psoriasis Area and Severity Index
Assessment of severity of psoriasis by comparing the change in Psoriasis Area and Severity Index between test and comparator (score ranging from 0 to 72, higher score means worsening of the disease)
Measured: Baseline to 8 weeks Post-randomization
Secondary outcomes (6)
Assessment of Physician's Global Assessment (PGA)
Proportion of patients achieving PGA 0 or 1 with Test and comparator
Measured: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Incidence of Adverse Events and SAEs (Safety and Tolerability)
Incidence of Adverse Event and Serious Adverse Event between three treatment arms
Measured: Till 8 weeks Post-randomization
More than 50 % reduction in PASI Score (PASI 50)
Proportion of patients achieving >50 % reduction in PASI Score (PASI50) with Test and comparator
Measured: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
More than 75 % reduction in PASI Score (PASI 75)
Proportion of patients achieving >75 % reduction in PASI Score (PASI75) with Test and comparator.
Measured: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Change in Irritation based on Visual Analogue scale (VAS)
To evaluate change in irritation based on Visual Analogue scale between three treatment arms Visual Analogue scale (VAS) ranges from 0 to 10 (higher scores mean worse outcome)
Measured: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Change in itching based on Visual Analogue scale
To evaluate change in itching based on Visual Analogue scale between three treatment arms, Visual Analogue scale (VAS) ranges from 0 to 10 (higher scores mean worse outcome)
Measured: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start3 Oct 2018
- Primary completion6 Nov 2019
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Plaque PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadila Pharnmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden
- Responsible party
- Sponsor
- Investigators
- Anil Avhad, MBBS, Study director, Cadila Pharmaceuticals Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174598
- Sponsor's protocol ID
- CRSC16004
- Acronym
- AKP01
- Status last verified
- Feb 2022
- First submitted
- 30 Nov 2021
- Last updated
- 3 Mar 2022
- 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 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Randomized, Observer Blind, Parallel Group, Three Arms, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Topically Applied Calcipotriol/AKVANO 50 μg/g Cutaneous Solution Against Calcipotriol Ointment 50 Micrograms/g, Sandoz and Placebo in Patients With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05174598
- Acronym / sponsor ID
- AKP01 / CRSC16004
- Conditions
- Mild to Moderate Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Lipidor AB, Svärdvägen 13 SE-182 33 Danderyd, Sweden
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 3 Jan 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.
This study is a Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to moderate plaque psoriasis
Detailed description
Total 278 patients with mild to moderate plaque psoriasis were randomized into the study. Study medications were applied twice daily for 8 weeks of study duration.
Patient's condition was assessed using of Physician's Global Assessment (PGA) and PASI Scale.
Primary objective of this study is to assess the therapeutic equivalence of Calcipotriol/AKVANO, 50 μg/g cutaneous solution with Calcipotriol Ointment 50 micrograms/g, Sandoz based on PASI score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcipotriol/AKVANO, 50 μg/g cutaneous solution | Experimental | Drug: Calcipotriol/AKVANO, 50 μg/g cutaneous solutionSpray formulation applied topically, twice daily, for the duration of 8 weeks. |
| Calcipotriol Ointment 50 micrograms/g, Sandoz | Active comparator | Drug: Calcipotriol Ointment 50 micrograms/gOintment applied topically, twice daily, for the duration of 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboSpray formulation applied topically, twice daily, for the duration of 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients (Non-pregnant) of plaque psoriasis aged 18 to 65 years having either Fitzpatrick skin type I-III or IV-VI.<br/>
- Diagnosis of stable plaque psoriasis for 6 month by a dermatologist with lesions on arms, legs or trunk.
- Mild to moderate psoriasis on Physician's global assessment (PGA),
- Body Surface Area (BSA) involvement of 5-10% (both included) and PASI ≥ 5.
- Patients must be willing to provide written informed consent and willing to comply with study requirements
Key exclusion criteria (14 listed)
- Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
- Patient with any uncontrolled systemic disease
- Patient with positive serology tests like HIV, HCV \& HBsAg.
- Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
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 |
|---|---|---|
| Calcipotriol/AKVANO, 50 μg/g cutaneous solutionTopical spray formulation containing Calcipotriol 50 μg/g. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks. | Drug | Calcipotriol/AKVANO, 50 μg/g cutaneous solution |
| Calcipotriol Ointment 50 micrograms/gTopical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks. | Drug | Calcipotriol Ointment 50 micrograms/g, Sandoz |
| PlaceboTopical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks. | Other | Placebo |
Primary outcome
Change in Psoriasis Area and Severity Index
Time frame: Baseline to 8 weeks Post-randomization
Assessment of severity of psoriasis by comparing the change in Psoriasis Area and Severity Index between test and comparator (score ranging from 0 to 72, higher score means worsening of the disease)
6 secondary outcomes
Assessment of Physician's Global Assessment (PGA)
Time frame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Incidence of Adverse Events and SAEs (Safety and Tolerability)
Time frame: Till 8 weeks Post-randomization
More than 50 % reduction in PASI Score (PASI 50)
Time frame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
More than 75 % reduction in PASI Score (PASI 75)
Time frame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Change in Irritation based on Visual Analogue scale (VAS)
Time frame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
Change in itching based on Visual Analogue scale
Time frame: Baseline to 2, 4 and 8 weeks of treatment Post-randomization
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 3 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Mild to Moderate Plaque Psoriasis
RecruitingPhase 1
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
Psoriasis, Healthy
Not yet recruiting
Pentoxifylline Add-On Therapy for Mild-to-Moderate Plaque Psoriasis
Psoriasis
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
Not yet recruitingPhase 2
A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis
Psoriasis
RecruitingPhase 1
Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques
Psoriasis
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.
Anil Avhad, MBBS study director
Cadila Pharmaceuticals Limited
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcipotriol/AKVANO, 50 μg/g cutaneous solution and Calcipotriol Ointment 50 micrograms/g in people with Mild to Moderate Plaque Psoriasis, run by Cadila Pharnmaceuticals at 14 sites in India.
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 14 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in Psoriasis Area and Severity Index (time frame: Baseline to 8 weeks Post-randomization). 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 3 Mar 2022.