| CTRI Number |
CTRI/2022/06/043333 [Registered on: 17/06/2022] Trial Registered Prospectively |
| Last Modified On: |
15/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of two topical vitamin D analogues in form of ointments in combination with phototherapy in treatment of psoriasis |
|
Scientific Title of Study
|
Comparative evaluation of topical calcipotriol plus Narrow Band ultraviolet B phototherapy versus topical calcitriol plus Narrow Band ultraviolet B phototherapy in treatment of psoriasis |
| Trial Acronym |
Calcipotriol vs calcitriol with NBUVB in psoriasis treatment |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha Chakraborty |
| Designation |
junior resident post graduate |
| Affiliation |
PT BD Sharma PGIMS Rohtak |
| Address |
Office of Head of Department of Dermatology Skin OPD Pandit BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9674074135 |
| Fax |
|
| Email |
docdishachaks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Aggarwal |
| Designation |
Professor |
| Affiliation |
PT BD Sharma PGIMS Rohtak |
| Address |
Office of Head of Department of Dermatology Skin OPD Pandit BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7988658303 |
| Fax |
|
| Email |
drkamalaggarwal@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Aggarwal |
| Designation |
Professor |
| Affiliation |
PT BD Sharma PGIMS Rohtak |
| Address |
Office of Head of Department of Dermatology Skin OPD Pandit BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7988658303 |
| Fax |
|
| Email |
drkamalaggarwal@live.in |
|
|
Source of Monetary or Material Support
|
| Pandit B.D. Sharma PGIMS Rohtak Haryana department of dermatology |
|
|
Primary Sponsor
|
| Name |
Kamal Aggarwal |
| Address |
Office of Head of Department Skin OPD Pandit B.D. Sharma PGIMS Rohtak Haryana |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Disha Chakraborty |
Skin OPD Pandit B.D. Sharma PGIMS Rohtak |
Office of Head of Department skin OPD Pandit B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA |
9674074135
docdishachaks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
topical calcipotriol plus NBUVB |
topical calcipotriol to be applied on right side along with NBUVB thrice per week |
| Comparator Agent |
Topical calcitriol plus NBUVB |
topical calcitriol to ne applied on left sided lesions along with NBUVB thrice per week |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with stable plaque psoriasis not exceeding 50% of body surface area involvement of age more than 18 years, according to the rule of nine, was included in this study. |
|
| ExclusionCriteria |
| Details |
• Patients of age 18 years and below.
• Patients who have used systemic antipsoriatic treatment or phototherapy within 2 months prior to the study.
• Patients having intolerance or previous failure to phototherapy.
• Patients using phototoxic drugs or drugs influencing psoriasis (lithium, beta blockers etc).
• Patients with hypersensitivity to calcipotriol or calcitriol.
• Patients with known hypercalcemia or hypersensitivity to calcipotriol.
• Patients with a history suggestive of photosensitivity or polymorphic light eruptions.
• Patients with previous or current carcinoma of the skin or actinic keratosis.
• Pregnant patients or lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy between topical calcipotriol and topical calcitriol |
to compare the difference of calcipotriol and calcitriol over 12 week period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety of the two combinations by assessing the adverse effects. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/06/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the clinical efficacy and safety of topical calcipotriol ointment with narrow band ultraviolet-B phototherapy versus topical calcitriol ointment and narrow band Ultraviolet-B phototherapy in the treatment of psoriasis. To compare the safety of the two combinations by assessing the adverse effects.
|