Plaque PsoriasisEarly Phase 1NCT05330936
Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment
A Early Phase 1 study testing Potent topical steroid in people with Plaque Psoriasis, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial summary
A randomized clinical trial with two groups. Group A Group B Group A is being treated with conventional Steroid combination ointment for the treatment of chronic Plaque Psoriasis. Group B is being treated with Cyanocobalamin in Avocado Oil cream for the treatment of chronic Plaque Psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Potent topical steroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 1 Sep 2022
- Phase
- Early 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age bracket (18-60 years)
- Non psoriatic Arthritis
- No oral Retinoids
Who cannot join
- pregnancy
- Malignancy
- Body surface area involving >50%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment in the Treatment of Chronic Plaque Psoriasi-A Randomized Clinical Trial in Tertiary Care Hospital
A randomized clinical trial with two groups. Group A Group B Group A is being treated with conventional Steroid combination ointment for the treatment of chronic Plaque Psoriasis.
Group B is being treated with Cyanocobalamin in Avocado Oil cream for the treatment of chronic Plaque Psoriasis.
Each group having 45 patients.
Read the detailed description
Outcome is being measured by PASI Score calculation with monthly follow up.
- Conditions
- Plaque Psoriasis
- Being tested
- Potent topical steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potent topical steroidCombination product
Cyanocobalamin in Avocado Oil Cream
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Steroid combination ointment in the treatment of chronic Plaque Psoriasis Receives: Combination Product: Potent topical steroid |
| Group B | Active comparator | Cyanocobalamin in Avocado Oil cream in the treatment of chronic Plaque Receives: Combination Product: Potent topical steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and tolerability of steroids as compared to Avacado Oil Cream
Compariaon of Efficacy of Steroid combination ointment in the treatment of chronic Plaque Psoriasis
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Jan 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishtiaq Ahmed, Pak Emirates Military Hospital
- Investigators
- Qamar ud din Khan, MBBS,FCPS, Study director, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330936
- Sponsor's protocol ID
- PakEmiratesMH
- Status last verified
- May 2023
- First submitted
- 23 Mar 2022
- Last updated
- 24 May 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 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment in the Treatment of Chronic Plaque Psoriasi-A Randomized Clinical Trial in Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT05330936
- Acronym / sponsor ID
- PakEmiratesMH
- Conditions
- Plaque Psoriasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 15 Apr 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.
A randomized clinical trial with two groups. Group A Group B Group A is being treated with conventional Steroid combination ointment for the treatment of chronic Plaque Psoriasis.
Group B is being treated with Cyanocobalamin in Avocado Oil cream for the treatment of chronic Plaque Psoriasis.
Each group having 45 patients.
Detailed description
Outcome is being measured by PASI Score calculation with monthly follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Combination Product: Potent topical steroidSteroid combination ointment in the treatment of chronic Plaque Psoriasis |
| Group B | Active comparator | Combination Product: Potent topical steroidCyanocobalamin in Avocado Oil cream in the treatment of chronic Plaque |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age bracket (18-60 years)
- Non psoriatic Arthritis
- No oral Retinoids
Key exclusion criteria (3 listed)
- pregnancy
- Malignancy
- Body surface area involving >50%
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 |
|---|---|---|
| Potent topical steroidCyanocobalamin in Avocado Oil Cream | Combination product | Group A, Group B |
Primary outcome
Efficacy and tolerability of steroids as compared to Avacado Oil Cream
Time frame: 12 weeks
Compariaon of Efficacy of Steroid combination ointment in the treatment of chronic Plaque Psoriasis
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 24 May 2023.
- 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.
Qamar ud din Khan, MBBS,FCPS study director
Pak Emirates Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Potent topical steroid in people with Plaque Psoriasis, run by Pak Emirates Military Hospital at 1 site in Pakistan.
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 3 inclusion and 3 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 24 May 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 Pakistan. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Efficacy and tolerability of steroids as compared to Avacado Oil Cream (time frame: 12 weeks). 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 24 May 2023.