| CTRI Number |
CTRI/2023/03/050273 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study of acne scars and research on best treatment modality for depressed acne scars |
|
Scientific Title of Study
|
A Clinical Study of Acne Scars and Split-face comparative study of Fractional CO2 Laser vs Fractional CO2 Lazer with Platelet-rich Plasma Theray in Treatment of Atrophic Acne Scars |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sebastian Thomas |
| Designation |
Post Graduate |
| Affiliation |
Rajiv Gandhi University of Health Sciences Bangalore |
| Address |
Yenepoya Medical College Hospital
Derlakatte,Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8547145988 |
| Fax |
|
| Email |
sebastianthomas1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal B |
| Designation |
Post Graduate |
| Affiliation |
Rajiv Gandhi University of Health Sciences Bangalore |
| Address |
Yenepoya Medical College Hospital
Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9880299783 |
| Fax |
|
| Email |
drvishalamin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sebastian Thomas |
| Designation |
Post Graduate |
| Affiliation |
Rajiv Gandhi University of Health Sciences Bangalore |
| Address |
Yenepoya Medical College Hospital
Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8547145988 |
| Fax |
|
| Email |
sebastianthomas1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Yenepoya Medical College Hospital |
| Address |
Yenepoya Medical College Hospital, Deralakatte,Mangalore,575018 |
| 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 |
| Sebastian Thomas |
Yenepoya Medical College Hospital |
Department of Dermatology, OPD number-7, Deralakatte,Mangalore 575018
Dakshina Kannada
KARNATAKA |
8547145988
sebastianthomas1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional CO2 Laser therapy along with Platelet rich plasma therapy in treatment of atrophic acne scars. |
Fractional CO2 Laser along with Platelet rich plasma therapy will be used on right side of face for treatment of atrophic acne scars- Study side
The procedure will be done a total of 4 times at 1 month interval each, i.e- Baseline, 1st, 2nd and 3rd, follow up. For a total duration of 4 months |
| Comparator Agent |
Fractional CO2 Laser therapy in treatment of atrophic acne scars |
Fractional CO2 Laser therapy alone will be used on left side of face for treatment of atrophic acne scars- Control side.
The procedure will be done a total of 4 times at 1 month interval each, i.e- Baseline, 1st, 2nd and 3rd, follow up. For a total duration of 4 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with acne scar for clinical study
Patients with grade 3and 4 acne scars for interventional study |
|
| ExclusionCriteria |
| Details |
Patients with HIV, HBV, Reccurent HSV.
Patients with bleeding manifestations.
Patients with keloidal tendencies.
Patients with unrealistic expectations and not willing for follow-up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will be able to clinically grade acne scars for the purpose of finding best possible treatment modality for treatment of atrophic acne scars |
1- Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will be able to compare the efficacy and safety of Fractional CO2 Laser Therapy with Platelet-rich Plasma Therapy versus Fractional CO2 Laser Therapy alone in treatment of atrophic acne scars. |
2- 4th week,
3- 8th week and
4- 12th week |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
15/03/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To
clinically evaluate and grade acne scars, and to compare efficacy and safety of fractional
co2 laser versus fractional co2 laser with platelet rich plasma therapy in the treatment
of atrophic acne scars.
Primary
objective: To determine the frequency of various types and grading of acne scars.
Secondary
objective: To evaluate the efficacy and safety of fractional co2 laser
versus fractional co2 laser with
platelet rich plasma therapy in the treatment of atrophic acne scars.
Rationale for the study: Grading and classifying acne scars will assess the
severity and prioritizes the choice of treatment. Many
treatment options are available for atrophic acne scars, but still, it is
challenging to manage as the condition can be refractive. Gold standard
treatment modality for atrophic acne scars are ablative lasers. Platelet rich
plasma therapy is a newer treatment modality used for atrophic acne scars,
which may have additional benefits compared to laser therapy alone. This
study intends to compare the efficacy and safety of fractional co2 laser and
platelet rich plasma therapy, for the treatment of atrophic acne scars. |