| CTRI Number |
CTRI/2024/12/077763 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the efficacy of shouldering in atrophic box car acne scars using ablative lasers |
|
Scientific Title of Study
|
A split face study to evaluate the efficacy of shouldering in atrophic box car acne scars using ablative lasers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS-DS-026, Version 1, Dated:08 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatosurgery
Rooma No: 10
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore
Bangalore
KARNATAKA
560040
India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatosurgery
Rooma No: 10
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore
KARNATAKA
560040
India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatosurgery
Rooma No: 10
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore
KARNATAKA
560040
India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciences
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Madura C |
CUTIS Academy of Cutaneous Sciences |
Department of Dermatosurgery
Room No:10
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040
Bangalore
KARNATAKA |
9632741998
maduradr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CUTIS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L909||Atrophic disorder of skin, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ablative Co2 laser |
Probe at 0.5-0.8 watt; 20Hz will be done for box car scars on the right side of the face. Topical moisturizing cream and desonide 0.05% lotion will be applied for 5 days for the treated area. Total of 4 sessions every 6 weeks |
| Comparator Agent |
Fractional ablative laser |
Combined Co2 and Er:Glass mode; Co2 at 8-12 watt; HP mode; Er:Glass 2-3 Watt; 5ms; 700-850 spacing) for the scar area and only fractional laser ablation will be done on the left side of the face. Topical moisturizing cream and desonide 0.05% lotion will be applied for 5 days for the treated area. Total of 4 sessions every 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Those who did not receive any other surgical treatment for acne scars in last 3 months
2.Patients with acne scars with Goodman Baron qualitative grade 2 or above. |
|
| ExclusionCriteria |
| Details |
1.Active infections
2.Keloidal tendency
3.Active acne
4.HIV(Human Immunodeficiency Virus), HbsAg(Hepatitis B surface Antigen), HCV (Hepatitis C) seropositivity
5.Facial scars due to causes apart from acne.
6.History of internal malignancies, diabetes mellitus, hypertension.
7.Pregnancy and lactation
8.History of surgical procedures for treatment of acne scars within last 3 months
9.Not willing to give informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical efficacy of shouldering of box car scars using fractional CO2 laser |
After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Topical moisturizing cream and desonide 0.05% lotion will be applied for 5 days for the treated area. Total of 4 sessions of fractional ablative laser at intervals of 6 weeks will be done on both sides; shouldering will be done only at first session and repeated at next session only if necessary. At every session; clinical photographs and ANTERA 3D analysis will be done. Goodman & Baron qualitative and quantitative scar scores will be recorded at each visit. |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 4 |
|
Date of First Enrollment (India)
|
19/12/2024 |
| 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="0"
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
|
Post acne scars is one
of the most common complaints of patients attending Dermatology OPD. Multiple treatment options like chemical
peels, microdermabrasion, skin microneedling, lasers, etc. have been used till
date for treatment of post acne scars. Response of acne scar treatments depends
upon scar type, scar duration, scar grade and the treatment modality used.
Despite of the availability of multiple treatment modalities for acne scars
satisfactory results are variable.
Surgical shouldering of
boxcar scars involves conversion of deeper boxcar scars to more superficial
scars; thus improving the outcome; but no literature is available if
shouldering is contributing to the improvement for these scars. This study aims
to evaluate the efficacy of this procedure in management of acne scars. |