| CTRI Number |
CTRI/2023/09/058063 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of the SCAR CLEARING GEL to treat Scars. |
|
Scientific Title of Study
|
A Prospective, Double Arm, Comparative, Clinical Study To Evaluate The Efficacy And Safety Of GLAZE SCAR CLEARING GEL With Mederma Scar Gel In Patients With Recent Scars. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SCARGEL/11/23 Ver 1.0 Date : 28-06-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Brinda G David |
| Designation |
Consultant Dermatologist |
| Affiliation |
Brindas Skin Clinic |
| Address |
No 265, Bussy Street near kamban kalaiarangam above alpha clinic Puducherry
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY
605001
India |
| Phone |
9751628254 |
| Fax |
|
| Email |
docbrinz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Thirumalai medical Centre, ki3 |
| Address |
Thirumalai Medical Centre, Room No 1, THirumalai Medical Centre, No 408, Cuddalore Road Nainarmandapam Puducherry
NO 5/3 JAYALAKSHMI STREET RADHA NAGAR CHROMPET
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
CEO |
| Affiliation |
KI3, CRO |
| Address |
KI3,Room No1 , KI3 OFFICE Regus Centre Level Altius Block No 1 SIDCO Industrial Estate Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Pontika Aerotech Ltd., Johron, Himachal Pradesh 173025 |
|
|
Primary Sponsor
|
| Name |
Pontika Aerotech Ltd. |
| Address |
Pontika Aerotech Limited Vill Johron,PO Puruwala,Nahan Road, Paonta Sahib,Dist-Srimour,Himachal Pradesh - 173001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Brinda G David |
Brindas Skin Clinic |
Room no. 2, Brinda’s Skin Clinic Pondicherry
Pondicherry
PONDICHERRY |
9751628254
docbrinz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L905||Scar conditions and fibrosis of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GLAZE SCAR CLEARING
GEL |
Dimethicone and Dimethicone/Vinyl Dimethicone Crosspolymer IH 80.00%(W/W)
Propylene Glycol Monocaprylate IH 4.00% (w/w)
L-ascorbic Acid IH/IP 5.00 % (w/w)
Aloe vera oil IH 0.1% (w/w)
Butylated Hydroxytoluene IH/IP 0.1% (w/w)
Fragrance IH 0.9% (w/w)
Tocopherol Acetate IH 0.05 % (w/w)
Caprylic / Capric Triglyceride IH 9.8 %(w/w)
Applied twice daily topically for 8 weeks duration |
| Comparator Agent |
MEDERMA SCAR GEL |
Aqua, PEG-200, Alcohol, Xantham Gum, Allium Cepa Bulb Extract, Allantoin, Panthenol, Parfum, Lecithin, Methylparaben, Sorbic Acid, Sodium Hyaluronate.
Applied twice daily topically for 8 weeks duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects in the age group of 18-50 years
2. Subject having visible recent scars (Face region) because of any trauma,
acne, dermatitis, Accidental scar, Surgery Scar and Scars after pregnancy.
3. Subject is having apparently healthy skin without any open wounds, cuts,
abrasions, irritation symptoms on test area.
4. Subjects willing to give voluntary written informed consent.
5. Subjects willing to come for regular follow up visits
6. Subjects willing to avoid unnecessary sun exposure during the study
period and willing to use Sun screens. |
|
| ExclusionCriteria |
| Details |
1. Subjects with a history of collagen vascular disease, cutis laxica,
connective tissue disease, psoriasis, or lupus.
2. Subjects diagnosed with scleroderma.
3. Subjects with any kind of skin allergy or cutaneous disease which
may influence the study results.
4. Subject with any significant medical condition/ severe co-morbid
disease conditions that would interfere with the participation in the
trial
5. Subjects participated in any other cosmetic or therapeutic trial or in
a similar investigation
6. Subjects having undergone facial treatments like bleaching or laser in last
30 days.
7. Hypersensitivity to any of the ingredients of the test product.
8. Pregnant or lactating women
9. Patients on steroid therapy or any other immunomodulatory agents. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Instrumental Assessment–
-Mexameter (Marked scar)- pre and post study
-Cutometer (Marked scar)- pre and post study
2. Vas Scar scoring
3. Skin moisture
4. Skin brightening
5. Skin smoothening
|
DAy 0,DAy 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome TimePoints
Patient and Investigator Feedbacks will be obtained
Adverse event monitoring |
Screening visit, Day 0, Day 15, Day 30, Day 45, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/10/2023 |
| Date of Study Completion (India) |
01/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 30 Participants will be randomized into two groups with 15 in each.
The application of the product will be done at each site on each day of assessment/ throughout the study period by the subject. Subject will wash their test area with a water prior to the application. After pat dry, the test product will be applied on the entire scar area of each application ( approximately 8-12 hours apart) twice daily throughout the study duration. After application, the subject should not wash their test site for at least 2 hours with water or any other product. Subjects will avoid unnecessary sun exposure immediately after morning product application. The daily application of the test product will be recorded in the subject dairy. Subjects will be asked to visit clinical facility/ institution for their follow up at the end of day 30, day 45, day 60 and any other additional visits if needed.
Primary and Secondary Outcome
1)VAS Score 2) Skin Moisture 3) Skin Scar Lightening 4) Skin Clarity 5) Skin Smoothening 6) Overall improvement of skin health 7) In terms of Burning/ Itching 8) Instrumental Assessment- Mexameter, Cutometer 9) Subject Assessment 10) Cosmetic Assessment
|