| CTRI Number |
CTRI/2021/01/030358 [Registered on: 11/01/2021] Trial Registered Prospectively |
| Last Modified On: |
05/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of patients with chronic plaque psoriasis receiving bath PUVA therapy using dermatoscope (non-invasive instrument). |
|
Scientific Title of Study
|
Dermatoscopic evaluation of patients with chronic plaque psoriasis receiving bath PUVA therapy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krithiga M |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology
Room no.21 2nd floor OPD building Kasturba Medical College Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9551628580 |
| Fax |
|
| Email |
krithiga.m@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghavendra Rao |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology
Room no.21 2nd floor OPD building Kasturba Medical College Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845292640 |
| Fax |
|
| Email |
jenny.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Krithiga M |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology
Room no.21 2nd floor OPD building Kasturba Medical College Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9551628580 |
| Fax |
|
| Email |
krithiga.m@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College , Manipal Academy of Higher Education , Manipal |
|
|
Primary Sponsor
|
| Name |
Krithiga M |
| Address |
Department of Dermatology,
Room no. 21, 2nd floor OPD building, Kasturba Medical College, Manipal Academy Of Higher Education, Manipal |
| 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 |
| Krithiga M |
Kasturba Medical College, Manipal |
Department of Dermatology
Room no.21, 2nd floor, OPD building, Kasturba Medical College, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA |
9551628580
krithiga.m@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult males or females with chronic plaque psoriasis receiving bath PUVA therapy |
|
| ExclusionCriteria |
| Details |
pregnant or lactating women,
erythrodermic / pustular psoriasis,
history of photosensitivity or cutaneous malignancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatoscopic findings that may indicate response to Bath PUVA treatment in patients with plaque psoriasis |
3rd, 5th, 7th sessions of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in PASI(Psoriasis Area Severity Index) score and LPSI (Local Psoriasis Severity Index) score |
3rd, 5th, 7th sessions |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
15/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is an observational study to assess and correlate between the clinical and dermatoscopic findings in psoriatic lesions in patients undergoing bath PUVA (Psoralen and Ultraviolet A) therapy. It is being conducted in a tertiary care hospital in India. The dermatoscopic findings can help us to assess the response to therapy , predict relapse in each individual patient and detect clinically invisible changes of steroid-induced side effects in patients concurrently using them. Clinical assessment is done using the PASI (Psoriasis Area Severity Index) score and LPSI (Local Psoriasis Severity Index) score. After each session of therapy, the response to treatment is graded according to percentage improvement in the PASI and LPSI score from baseline and correlated with the dermatoscopic findings |