| CTRI Number |
CTRI/2024/06/069015 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Chemical peeling] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative study between efficacy of two combination peels in acne vulgaris grade II and III |
|
Scientific Title of Study
|
Comparative study between efficacy of 18 percent Salicylic acid and 15 percent Azelaic acid combination peel vs 20 percent Salicylic acid and 10 percent Mandelic acid combination peel in Acne vulgaris grade II & III - A 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 Bhakti Sarda |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research |
| Address |
Room no 114, Block E, 1st floor, Dept of Dermatology, Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9130022888 |
| Fax |
|
| Email |
bhaktis0108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhushan Madke |
| Designation |
Professor & Head, Dept of Dermatology, AVBRH, Sawangi |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research |
| Address |
Room no 114, Block E, 1st floor, Dept of Dermatology, Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
7066887353 |
| Fax |
|
| Email |
drbhushan81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhushan Madke |
| Designation |
Professor & Head, Dept of Dermatology, AVBRH, Sawangi |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research |
| Address |
Room no 114, Block E, 1st floor, Dept of Dermatology, Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
7066887353 |
| Fax |
|
| Email |
drbhushan81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru medical college, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha, Pin code 442004 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru medical college, DMIHER, Sawangi Meghe Wardha |
| Address |
Jawaharlal Nehru medical college, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha, Pin code 442004 |
| Type of Sponsor |
Other [Deemed University] |
|
|
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 Bhakti Sarda |
Acharya Vinoba Bhave Rural Hospital |
Room no 114, Block E, Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha, 442004
Wardha
MAHARASHTRA |
9130022888
bhaktis0108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Intervention |
18% Salicylic acid and 15% Azelaic acid combination peel |
Intervention group will be treated with 18% salicylic acid + 15% azelaic acid combination peel for Acne vulgaris grade II & III. The participants will be graded according to IAA (Indian Acne Alliance) grading in the very first visit which will be considered as baseline. They will be then followed up after every 2 weeks for maximum 6 sittings or till achievement of grade I whichever is earlier with grading done in every visit. |
| Comparator Agent |
20% Salicylic acid and 10% Mandelic acid combination peel |
Comparator group will be treated with 20% salicylic acid + 10% mandelic acid combination peel for Acne vulgaris grade II & III. The participants will be graded according to IAA (Indian Acne Alliance) grading in the very first visit which will be considered as baseline. They will be then followed up after every 2 weeks for maximum 6 sittings or till achievement of grade I whichever is earlier with grading done in every visit. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18 years of age.
2. Patients who have given written consent before any treatment is commenced.
3. Clinically Diagnosed cases of acne vulgaris grade II & grade III. |
|
| ExclusionCriteria |
| Details |
1. Patients with active herpes simplex infection, viral warts, molluscum contagiosum or any other local site infection.
2. Patients who are on systemic medication for acne vulgaris for the past 3 months or topical medication for the past 1 month.
3. Patient on photosensitive drugs like tetracyclines.
4. Patients with history of hypertrophic scars and keloid.
5. Patients with unrealistic expectations.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in lesions of acne vulgaris with both Salicylic Acid + Mandelic Acid and Salicylic Acid + Azelaic Acid combination peels using IAA (Indian Acne Alliance) grading of acne. |
Will be assessed at baseline, then every 2 weeks till maximum 6 sittings |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time required to achieve grade I in case of both the peels |
Will be assessed at baseline, then every 2 weeks till maximum 6 sittings |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="1"
Months="6"
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
|
One of the most common illnesses affecting adolescents is acne vulgaris. It causes discomfort on a physical and psychological level and is typified by the development of lesions with or without pigmentation and scarring, usually over the face but occasionally over the trunk. Different oral and topical drugs, as well as techniques including chemical peeling and microneedling, are used to treat it. One safe and efficient way to treat this issue is chemical peeling. In this randomised controlled experiment, the effectiveness of two different peeling techniques—Group 1 using a combination of 18% salicylic acid and 15% azelaic acid and Group 2 using a combination of 20% salicylic acid and 10% mandelic acid—in treating Acne vulgaris grades II and III is being compared. On the initial visit, which will serve as the baseline, the participants will be rated in accordance with the Indian Acne Alliance (IAA) grading system. Following then, they will be checked on every two weeks for a maximum of six sittings, or until they attain grade I, whichever comes first, with each visit involving grading. The significance difference for comparison groups at the 5% level (P<=0.05) will be determined using the T-test. The active control group consisted of salicylic acid plus azelaic acid combination peel, while the experimental group consisted of salicylic acid plus mandelic acid combination peel. The IAA grade of acne, which is a categorical variable, will be evaluated using the Fisher exact test to determine the significance of the correlation at various risk variables. Multivariate analysis will be used to examine all confounding variables. The Scientific Scrutiny/Institutional Research Committee and the Institutional Ethics Committee (IEC) have both approved. Every participant will be required to provide written, informed consent, and both during and after the study, the privacy of their personal data will be guaranteed.
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