| CTRI Number |
CTRI/2023/10/059321 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Other |
|
Public Title of Study
|
To compare which is more better between Lactosporin 2% Gel Versus Adapalene 0.1% Gel to treat Acne Vulgaris |
|
Scientific Title of Study
|
To Compare The Therapeutic Efficacy Of Lactosporin 2% Gel Versus Adapalene 0.1% Gel In The Treatment Of Mild To Moderate Acne Vulgaris- A Randomized Comparative 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 |
Dr V Sivasubramanian |
| Designation |
Head of Department |
| Affiliation |
Vinayaka Missions Medical College and Hospitals, Karaikal |
| Address |
Department of Dermatology, Venereology and Leprosy,
Vinayaka Missions Medical College
Karaikal
Pondicherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9884835199 |
| Fax |
|
| Email |
hoddvdvmmckkl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Sivasubramanian |
| Designation |
Head of Department |
| Affiliation |
Vinayaka Missions Medical College and Hospitals, Karaikal |
| Address |
Department of Dermatology, Venereology and Leprosy,
Vinayaka Missions Medical College
Karaikal
Pondicherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9884835199 |
| Fax |
|
| Email |
hoddvdvmmckkl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aakrith Dhaksh Dewan |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospitals, Karaikal |
| Address |
Department of Dermatology, Venereology and Leprosy,
Vinayaka Missions Medical College
Karaikal
Pondicherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9845791382 |
| Fax |
|
| Email |
akidewan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions research foundation, Karaikal, Kottucherry Post, Pondicherry, 609609 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College |
| Address |
Keezhakasakudymedu, Karaikal, Pondicherry |
| Type of Sponsor |
Private medical college |
|
|
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 V Sivasubramanian |
Vinayaka Missions Medical College |
Department of Dermatology, Venereology and Leprosy,
Karaikal
Pondicherry
Karaikal
PONDICHERRY |
9884835199
hoddvdvmmckkl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Vinayaka Missions Medical College |
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 |
Adapalene 0.1% gel |
In patients with mild to moderate Acne Vulgaris Adapalene 0.1% Gel will be applied once a day(at night) for a period of 4 weeks |
| Comparator Agent |
Lactosporin 2% Gel |
In patients with Mild to moderate Acne Vulgaris, Lactosporin 2% Gel will be applied twice daily(morning, night) for a period of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with Mild to moderate acne vulgaris
2)Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating mothers
2)Patients allergic to Lactosporin and Adapalene
3)Patients who used topical corticosteroids ,antibiotics or retinoids within the past two weeks on the faceÂ
4)Patients who used systemic corticosteroids, antibiotics or retinoids within the past 1 month
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the clinical response with the help of Global acne grading system and comparing the therapeutic efficacy of Adapalene 0.1% Gel versus Lactosporin 2% Gel in the treatment of mild to moderate Acne Vulgaris |
Every week during the course of treatment, at the end of 4 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Treatment side effects,
Recurrence |
For a period of 4 weeks after cessation of treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/11/2023 |
| 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="0"
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
|
Clinical diagnosis will be made based on detailed history and examination After applying Inclusion and exclusion criteria patients will be selected for the study. History and written consent from the patient is taken
For Group A patients :- The patients will be advised to apply Lactosporin 2% Gel twice a day (morning and night) for 4 weeks. Follow up will be done every week For Group B patients :- The patients will be advised to apply Adapalene 0.1% Gel once a day (at night). Follow up will be done every week
The dermatological assessment will be performed using the Global acne grading system at the beginning of the study and then weekly.
Patients of both groups will be followed up for a period of 4 weeks after cessation of treatment, to check for any recurrence
The study will be concluded with the comparison of clinical improvement of both Group A and Group B study population |