| CTRI Number |
CTRI/2024/11/076193 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy and safety of ultra low dose vs low dose isotretinoin in moderate to severe acne |
|
Scientific Title of Study
|
Efficacy and safety of ultralow dose isotretinoin versus low dose isotretinoin for the management of moderate to severe acne vulgaris: a single blinded randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Teertha Thamminaina |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),Pondicherry |
| Address |
Department of Dermatology and STD IPD block(ward26) JIPMER
pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8639796030 |
| Fax |
4132296000 |
| Email |
teertha.thamminaina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Kumari |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER),Pondicherry |
| Address |
Department of Dermatology and STD, rRoom no :106 IEC (human studies) Dean research office,first floor,administrative block JIPMER Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9489692199 |
| Fax |
4132296000 |
| Email |
rashmi.sreerag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Kumari |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER),Pondicherry |
| Address |
Department of Dermatology and STD, rRoom no :106 IEC (human studies) Dean research office,first floor,administrative block JIPMER Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9489692199 |
| Fax |
4132296000 |
| Email |
rashmi.sreerag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research campus Rd, Gorimedu,Dhanvantari nagar,Puducherry,605006 country: India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Educators and Research JIPMER ,Pondicherry |
| Address |
Department of Dermatology
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER),Gorimedu,Dhanvanthri Nagar Pondicherry .Pondicherry 605006 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| teertha thamminaina |
Jawaharlal institute of Postgraduate Medical education and research |
Department of DERMATOLOGY OPD and IPD division room number 85, ward26/ward 02
Pondicherry
PONDICHERRY |
8639796030
teertha.thamminaina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEEINTERVENTIONALSTUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A- Ultra low dose oral isotretinoin
|
0.3mg/kg of ultra low dose oral isotretinoin will be given to patients randomised into group A
and dose will be decreased or stopped if complete clearance or dose will be increased to 0.6mg/kg if no clinical clearance seen at the end of 6th month |
| Comparator Agent |
Group B-low dose oral isotretinoin |
0.6mg/kg of low dose oral isotretinoin will be given to patients randomised into group B and dose will be decreased or stopped if complete clearance or dose will be increased to 1mg/kg if no clinical clearance seen at the end of 6th month |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 14 years
Patients with moderate to severe acne (GAGSscore greater than 19)
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Leucopenia with leucocyte count less than 4000 per microlitre
Liver enzymes (ALT/AST) above the upper limit of reference range
Moderate to severe cholesterol and triglycerides elevation
Deranged renal function test
Known case of Hepatitis B or hepatitis C.
Concomitant use of other hepatotoxic drugs
Any preexisting liver disease
Sexually active females of reproductive age group who are not willing to use contraception as required.
Patients on any other immunosuppressive, immunomodulatory drugs or on drugs that has significant interaction with isotretinoin
Known case of psychiatric disease
Known hypersensitivity reaction to isotretinoin.
Patients with baseline transaminitis (ALT OR AST greater than 50)
Dyslipidemia
Patient on any systemic therapy for acne in last 4 weeks
Patients with clinical signs of hirsutism
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to observe Ultra-low dose of isotretinoin is non-inferior to low dose isotretinoin on clearance of acne among the patients with moderate to severe acne vulgaris. |
at baseline,3rd month,6th month and at the end of 1st year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the adverse effect profile among the patients with moderate to severe acne treated with ultra low dose and low dose isotretinoin. |
at baseline,3rd month,6th month and at the end of 1st year |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
our study is a randomised 1:1, parallel group,controlled single center, 12 month trial to be conducted in the outpatient department of dermatology, jipmer. patient in group A will recieve 0.3mg/kg ultra low dose of oral isotretinoin and group B will receive 0.6mg/kg of oral isotretinoin. Follow up assessment will be done at 3rd, 6th, 12th month for any flares.
Main efficacy for low dose isotretinoin will be measured at 3rd month and for ultra low dose at 6th month to keep the cumulative doses of isotretinoin comparable in both groups |