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Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Potent topical steroid
Sponsored by
Pak Emirates Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age bracket (18-60 years)
  • Non psoriatic Arthritis
  • No oral Retinoids

Exclusion Criteria:

  • pregnancy
  • Malignancy
  • Body surface area involving >50%

Sites / Locations

  • PakEmiratesMH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

Steroid combination ointment in the treatment of chronic Plaque Psoriasis

Cyanocobalamin in Avocado Oil cream in the treatment of chronic Plaque

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 23, 2022
Last Updated
May 22, 2023
Sponsor
Pak Emirates Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05330936
Brief Title
Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pak Emirates Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. Each group having 45 patients.
Detailed Description
Outcome is being measured by PASI Score calculation with monthly follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Steroid combination ointment in the treatment of chronic Plaque Psoriasis
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Cyanocobalamin in Avocado Oil cream in the treatment of chronic Plaque
Intervention Type
Combination Product
Intervention Name(s)
Potent topical steroid
Intervention Description
Cyanocobalamin in Avocado Oil Cream
Primary Outcome Measure Information:
Title
Efficacy and tolerability of steroids as compared to Avacado Oil Cream
Description
Compariaon of Efficacy of Steroid combination ointment in the treatment of chronic Plaque Psoriasis
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age bracket (18-60 years) Non psoriatic Arthritis No oral Retinoids Exclusion Criteria: pregnancy Malignancy Body surface area involving >50%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qamar ud din Khan, MBBS,FCPS
Organizational Affiliation
Pak Emirates Military Hospital
Official's Role
Study Director
Facility Information:
Facility Name
PakEmiratesMH
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
92
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment

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