Health Condition 1: L910- Hypertrophic scar
Conditions
Sponsors
Regenxgen Biosolutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both Male and female patients aged above 3 years 2. Patients with post-surgical linear hypertrophic scars and/or keloids with Age of Hypertrophic Scars and/keloids between 2 months to 2 years and Size of Scar: Less than 30cm in length (Length 3. Patients who can understand and follow specific instructions of the hospital as far as application, removal, storage, and re-application of the study product in a systematic manner 4. Patients or patients with parents/guardians who can and are willing to provide written informed consent 5. Patient who understands and is willing to participate in the clinical study and can comply with scheduled visits as per the protocol and follow-up study procedures
Exclusion criteria
Exclusion criteria: 1.Patient with signs of wound dehiscence, wound infection, open wounds in the post-operative area at the time of first application 2. Patient who has received any type of hypertrophic scar or keloid treatment within 4 weeks prior to start of the current study or planning to undergo another parallel treatment for hypertrophic scars or keloids 3. Patients having history of developing genetic keloids 4. Patients with history of collagen vascular disease, connective tissue disease (cutis laxica), systemic psoriasis, lupus or scleroderma 5. Patient with known allergy/ hypersensitivity to medical tapes, or adhesives, silicone gel sheet or any of the individual polysiloxane based products 6. Patients with pitted or depressed scars as per clinical assessment 7. Patients having dermatological conditions (For example: Psoriasis, Eczema etc.) 8. Presence of any condition(s) that seriously compromises the patient’s ability to complete this study or has a known history of poor adherence with medical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in scar appearance 2. Effective reduction in total scar sizeTimepoint: Screening Period plus 24 weeks of treatment period assessed at Baseline Visit and follow up visits on Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event MonitoringTimepoint: 24 weeks of Study Period | — |
Countries
India
Contacts
Public ContactMr Hari Kishore Sridharan
REGENXGEN BIOSOLUTIONS PRIVATE LIMITED
Outcome results
None listed