| CTRI Number |
CTRI/2025/05/086346 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
04/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of fractional CO2 laser in combination with topical insulin in treatment of facial atrophic acne scars |
|
Scientific Title of Study
|
The safety and efficacy of Fractional CO2 laser with topical insulin versus Fractional CO2 laser alone in facial atrophic post-acne scar: A randomized split-face 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 |
Lavanya Raavi |
| Designation |
junior resident |
| Affiliation |
IMS AND SUM HOSPITALS |
| Address |
Department of Skin VD
ground floor, IMS and SUM hospital building,
Kalinga Nagar, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
09951001777 |
| Fax |
|
| Email |
munni.alku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikash Ranjan Kar |
| Designation |
professor and HOD |
| Affiliation |
IMS AND SUM HOSPITALS |
| Address |
Department of Skin VD
ground floor, IMS and SUM hospital building,
Kalinga Nagar, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
bikashkar@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bikash Ranjan Kar |
| Designation |
professor and HOD |
| Affiliation |
IMS AND SUM HOSPITALS |
| Address |
Department of Skin VD
ground floor, IMS and SUM hospital building,
Kalinga Nagar, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
bikashkar@soa.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of skin VD
ground floor, IMS and SUM hospital building,
Kalinga Nagar, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
IMS AND SUM HOSPITAL |
| Address |
k8,kalinga nagar ,odisha,751003 |
| 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 Bikash ranjan kar |
IMS AND SUM HOSPITALS |
Department of skin VD
ground floor, IMS and SUM hospital building,
Kalinga Nagar, Bhubaneswar
Khordha
ORISSA |
9937428181
bikashkar@soa.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS and SUM hospital |
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 |
Fractional CO2 laser with normal saline |
At each visit, the other side of the face will receive Fractional CO2 Laser (Fotona, SP Dynamics) with parameters Wavelength-10600nm, point energy- 8 mJ, 8W, residence time- 1ms, Interval time- 1ms, Point spacing- 0.8mm
Increase in 10% energy at each visit, along with a massage with normal saline -40 units for placebo effect
|
| Intervention |
Fractional CO2 with Topical insulin |
In each visit, the Fractional CO2 Laser (Fotona, SP Dynamics) with parameters
Wavelength-10600nm, point energy- 8 mJ, 8W, residence time- 1ms, Interval time- 1ms, Point spacing- 0.8mm
An increase of 10% in energy at each visit is done on one side of the face, followed by a massage with
Topical insulin- 1 ml (Human actrapid® insulin 40IU/ml) on the same side of the face, decided by computer-generated randomization
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Atrophic post Acne scar of any grade
Fitzpatrick skin type 3 to 6
No treatment (including surgical and laser therapy) within 12 weeks before being enrolled in the study.
|
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
Autoimmune disease, connective tissue disease
History of Photosensitivity
Use of immunosuppressive medications, active cancer, underlying illness (cardiac, neurological)
History of skin cancers, and presence of premalignant or malignant cutaneous lesions over the face.
History of keloidal tendency
Patient on isotretinoin therapy
Presence of hypertrophic scars
History of diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of topical insulin with fractional CO2 laser versus fractional CO2 alone in the treatment of PAS. |
0 week,4 weeks,8 weeks,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess the safety of topical insulin with fractional CO2 laser in the treatment of PAS.
To Assess the effect of topical insulin with fractional CO2 laser therapy on the quality of life in PAS patients
|
0 week,4 weeks,8 weeks,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/05/2025 |
| 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="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
|
This is a randomized split-face study that includes 30 atrophic post-acne scar patients meeting the inclusion and exclusion criteria, visiting the IMS and SUM Hospitals skin VD OPD. On each visit, pre- and post-procedure photographs along with grading of acne scars are done, and fractional CO2 with topical insulin on one side of the face is given, decided by computer-generated randomization, and fractional CO2 laser with topical normal saline is given on the other side of the face. Pre and post-procedure blood sugar levels are recorded, and post-procedure erythema and post-inflammatory hyperpigmentation scores are done on each visit |