| CTRI Number |
CTRI/2025/02/080180 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of a novel combination pimple patch versus conventional topical gel in acne patients. |
|
Scientific Title of Study
|
To study the effectiveness of novel combination hydrogel pimple patch containing Azelaic acid, Salicylic acid and Zinc oxide versus conventional topical spot treatment available for the treatment of acne vulgaris : a randomized control 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 Prathambigai S S |
| Designation |
Post-graduate resident |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Dermatology, Venerology and Leprosy
Fourth floor
Saveetha Medical College and Hospital,
Saveetha Nagar,
Thandalam,
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8056232348 |
| Fax |
|
| Email |
sspratha95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C.R.V. Narasimhalu |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Dermatology, Venerology and Leprosy
Fourth floor
Saveetha Medical College and Hospital,
Saveetha Nagar,
Thandalam,
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9445188988 |
| Fax |
|
| Email |
drnarasimhalu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Prathambigai S S |
| Designation |
Post-graduate resident |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Dermatology, Venerology and Leprosy
Fourth floor
Saveetha Medical College and Hospital,
Saveetha Nagar,
Thandalam,
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8056232348 |
| Fax |
|
| Email |
sspratha95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital,
Saveetha Nagar,
Thandalam,
Chennai- 602105
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Dr Prathambigai S S |
| Address |
Department of Dermatology, Venerology and Leprosy
Fourth floor
Saveetha Medical College and Hospital,
Saveetha Nagar,
Thandalam,
Chennai - 602105
Tamil Nadu
India
|
| 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 |
| Dr Prathambigai S S |
Saveetha Medical College and Hospital |
Department of Dermatology, Venerology and Leprosy
Out patient division
Room number 401
Chennai
TAMIL NADU |
8056232348
sspratha95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
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 |
Conventional spot acne treatment |
Deriva CMS gel containing 0.1% Adapalane and 1% Clindamycin manufactured by Glenmark Pharmaceuticals Ltd. It should be applied locally over a lesion once a day at night time topically for 6 hours till the lesion subsides. |
| Intervention |
Novel combination pimple patch |
It is a Carrageenan hydrogel patch containing 1% Salicylic acid, 3% Azelaic acid and Zinc oxide. It should be applied one patch per new lesion once a day at day time or night time topically for 6 hours till the lesion subsides. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18 and 40 years.
2.Patients clinically diagnosed with Pillsbury Grade 1 and 2 acne where lesion size is less than 1cm
3. Patients not on any other topical treatment for acne vulgaris
4. Patients who are reliable and compliant for regular follow-up
|
|
| ExclusionCriteria |
| Details |
1. Patients with Pillsbury Grade 3 and greater acne
2. Patients on other topical treatments for acne vulgaris
3. Patients having other dermatological conditions like Psoriasis, eczema
4. Children below the age of 18 years
5. Pregnant and lactating women
6. Patients with hypersensitivity/ allergy to Aspirin
7. Patients with hypersensitivity to hydrogel patch
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| erythema, diameter of lesions and pigmentation |
Days 1,3,5,7,10 after application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| physician assessment grading of lesions |
Days 1,3,5,7,10 after application |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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, open labelled, parallel group, single-centre trial comparing the safety and efficacy of a novel combination pimple patch containing 1% Salicylic acid, 3% Azelaic acid and Zinc oxide and a conventional spot treatment of 0.1% Adapalene and 1% Clindamycin combination gel for 6 months in 50 patients with acne vulgaris that will be conducted in Saveetha Medical College and Hospital, a tertiary care hospital in India. The primary outcome measures erythema, diameter and pigmentation at day 1,3,5, 7 and 10 of treatment . |