| CTRI Number |
CTRI/2024/02/062512 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To determine effectiveness of combined treatment using needle underneath the skin and laser for acne scars on face |
|
Scientific Title of Study
|
Efficacy of Combination of Subcision With Fractional Carbon Dioxide Laser On Patients With Atrophic Acne Scars On Face A Pre Post Interventional 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 Shreshthangsha Sayan Biswas |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Post Graduate Student Department of Dermatology Venereology and Leprosy
All India Institute of Medical Sciences Patna
Patna
BIHAR
801507
India |
| Phone |
8017076171 |
| Fax |
|
| Email |
ssb12th@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swetalina Pradhan |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Department of Dermatology Venereology and Leprosy
All India Institute of Medical Sciences Patna
Patna
BIHAR
801507
India |
| Phone |
7978843633 |
| Fax |
|
| Email |
dr.swetalinapradhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreshthangsha Sayan Biswas |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Post Graduate Student Department of Dermatology Venereology and Leprosy
All India Institute of Medical Sciences Patna
Patna
BIHAR
801507
India |
| Phone |
8017076171 |
| Fax |
|
| Email |
ssb12th@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna Bihar 801507 |
|
|
Primary Sponsor
|
| Name |
Dr Shreshthangsha Sayan Biswas |
| Address |
Post Graduate Student
Department of Dermatology Venereology and Leprosy
All India Institute of Medical Sciences Patna |
| 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 Shreshthangsha Sayan Biswas |
All India Institute of Medical Sciences Patna |
Department of Dermatology Venereology and Leprosy
All India Institute of Medical Sciences Patna
Patna
BIHAR |
8017076171
ssb12th@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Subcision And Fractional Carbon Dioxide Laser |
Patients of atrophic acne scars on face will undergo combination of subcision and fractional carbon dioxide laser treatment. Before starting the study baseline Goodman and Baron quantitative score Goodman and Baron qualitative grading Dermatology Life Quality Index score and Visual Analog Scale Score will be recorded. In the first session patient will undergo a single session of subcision of the atrophic acne scars on face using 18 gauge needle under local anesthesia followed by fractional carbon dioxide laser on the same day using energy 15 mJ deep mode scan size of 10x10mm density 5% 1.0 second of time off and exposure type will be repeat exposure. The laser settings will be kept the same for all sessions of laser treatment. Patient will then follow up every month for 3 more months only for undergoing fractional carbon dioxide laser treatment. In each follow up session, only Goodman and Baron quantitative score and Visual Analogue Scale score and details of any adverse effects will be noted. The final follow up session will be 1 month after the last session of laser treatment, when the patient will not undergo any procedure. Final details of Goodman and Baron quantitative score Goodman and Baron qualitative grading Dermatology Life Quality Index score and Visual Analog Scale Score will be recorded. Finally all these scores will be compared pre and post treatment to evaluate the efficacy of the treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 40 years.
No active acne lesions on face for example papules pustules nodules comedones cysts.
Patients having atrophic acne scars of grades 3 and 4 on face as per Goodman and Baron qualitative scale.
Patients consenting to be part of the study. |
|
| ExclusionCriteria |
| Details |
Patients on anticoagulation therapy.
Patients having any other photoaggravated disease.
Patients who have taken oral Isotretinoin in the past 6 months.
Patient taking topical treatment on face within the past 1 month.
Patients having a tendency to develop keloid scars.
Patients who have undergone filler or laser procedures on face in the past 1 year.
Patients having herpes labialis.
Pregnant and lactating women.
Patients with unrealistic expectations. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of combination of subcision with fractional carbon dioxide laser on patients suffering from atrophic acne scars using Goodman and Baron quantitative score |
Patients will be followed up every month for total of 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine patient satisfaction based on the Visual Analogue Scale scoring system in each follow up visit.
To compare the grade of atrophic acne scar as per Goodman and Baron qualitative scale before and after the completion of study.
To compare Dermatology Life Quality Index scores before and after the completion of study. |
Patients will be followed up every month for total of 4 months |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "71"
Final Enrollment numbers achieved (India)="71" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/02/2024 |
| Date of Study Completion (India) |
17/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Patients of atrophic acne scars on face will undergo combination of subcision and fractional carbon dioxide laser treatment. Before starting the study baseline Goodman and Baron quantitative score Goodman and Baron qualitative grading Dermatology Life Quality Index score and Visual Analog Scale Score will be recorded. In the first session patient will undergo a single session of subcision and fractional carbon dioxide laser. Patient will then follow up every month for 3 more months only for undergoing fractional carbon dioxide laser. The final follow up session will be 1 month after the last session of laser treatment, where the patient will not undergo any procedure. Only details of Goodman and Baron quantitative score Goodman and Baron qualitative grading Dermatology Life Quality Index score and Visual Analog Scale Score will be recorded. In each follow up session in between only Goodman and Baron quantitative score and Visual Analogue Scale score and details of any adverse effects will be noted. Finally all these scores will be compared pre and post treatment to evaluate the efficacy of the treatment. With these procedures the atrophic acne scars of patients will improve along with better cosmetic appearance and improved quality of life overall.
|