| CTRI Number |
CTRI/2024/07/071250 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Microbotox injection versus oral isotretinoin tablets in treating patients with oily skin and acne-A comparative study. |
|
Scientific Title of Study
|
A study to evaluate the efficacy and safety of microbotox versus oral isotretinoin therapy in treating seborrhea and acne-A randomized controlled pilot study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Satyanarayana |
| Designation |
Fellow in aesthetic dermatology |
| Affiliation |
Bangalore medical college and research institute, Bangalore |
| Address |
Department of Dermatology, Room no 53I, B block, Bangalore Medical College and Research Institute, Fort Road, Bangalore.
Bangalore
KARNATAKA
560002
India |
| Phone |
9036426752 |
| Fax |
|
| Email |
aishwarya.albi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Eswari L |
| Designation |
Associate Professor in Dermatology |
| Affiliation |
Bangalore medical college and research institute, Bangalore |
| Address |
Department of dermatology, B block, 1st floor, Bangalore Medical College and Research Institute, Fort Road, Bangalore.
Bangalore
KARNATAKA
560002
India |
| Phone |
9845935375 |
| Fax |
|
| Email |
eshwari.nithyanand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Satyanarayana |
| Designation |
Fellow in aesthetic dermatology |
| Affiliation |
Bangalore medical college and research institute, Bangalore |
| Address |
Department of dermatology, Room no 53I, 1st floor, B block, Bangalore Medical College and Research Institute, Fort Road, Bangalore.
Bangalore
KARNATAKA
560002
India |
| Phone |
9036426752 |
| Fax |
|
| Email |
aishwarya.albi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal investigator, fellow in aesthetic dermatology, Department of dermatology, Bangalore Medical College and Research Institute, Fort road, Bangalore-560002, India. |
|
|
Primary Sponsor
|
| Name |
Aishwarya Satyanarayana |
| Address |
Fellow in aesthetic dermatology, Room no 53I, B block, Department of Dermatology, Bangalore medical college and research institute, Fort road, Bangalore-560002, India. |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 |
| Dr Aishwarya Satyanarayana |
Bangalore medical college and research institute, Bangalore |
Dermatology out-patient department, Bangalore Medical College and Research Institute, Fort Road, Bangalore-560002.
Bangalore
KARNATAKA |
9036426752
aishwarya.albi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute, Bangalore |
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 |
| Comparator Agent |
Isotretinoin tablets |
Oral isotretinoin tablets at the dose of 20mg daily given for three months. |
| Intervention |
Microbotox injection |
Diluted botulinum toxin injection given into the skin of the face. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients above the age of 18 years, with seborrhea which meets the criteria as per skin oiliness and acne which requires isotretinoin therapy. Patients who are willing to provide informed consent will be considered for participation in the study. |
|
| ExclusionCriteria |
| Details |
Patients with active infection at injection site, neuromuscular disorders, known hypersensitivity to any ingredient of the injection. Pregnant and lactating women. Patients on oral steroid therapy, anticoagulant therapy, systemic retinoid intake in the previous six months. Patients with unrealistic expectations. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the subjective seborrhea severity graded on a scale of 1 to 10, 1 being mild and 10 being severe from baseline to 3 months. |
Reduction in the subjective seborrhea severity at baseline, 4weeks, 8weeks and 12weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the Comprehensive Acne Severity Score from baseline to 3 months. |
Baseline at 0weeks, follow up visits at 4,8,12 weeks. |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a randomized controlled study comparing the efficacy and safety of microbotox injection versus oral isotretinoin in treating acne and seborrhea. The study will include 15 patients in each treatment arm. The follow up will be at baseline, 4, 8 and 12 weeks. The outcome measures assessed will be reduction the severity of seborrhea and acne and adverse effects of therapy. |