To assess the safety, efficacy, and performance of the SILCONEX scar treatment gel that helps to reduce discolouration and redness whilst relieving the itching, discomfort, and pain associated with scars.
- Registration Number
- CTRI/2023/04/051466
- Lead Sponsor
- ENNOGEN Healthcare International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Paediatric (Children > 3 months) and adults
2. Subjects who are healthy or medically fit
3. Subjects who are willing to participate and able to follow study requirements
4. Subjects having recent scars and immature scars (6 months to 1 year)
5. Subjects having scars on the body parts, face, joints, flexures, hairy areas, and large area scars such as those caused by burns (less than 5%) or trauma and surgical/suture scars
6. Etiology and clinical assessment of the scar indicate that it could benefit from the study treatments
7. Only to be used on intact skin form of healing
1. Subjects with chronic skin diseases such as psoriasis, chronic dermatitis, and allergies
2. Subjects have a history of silicone allergy/sensitivity to rosehip oil, Ximenia oil, sandalwood oil, vitamin E acetate, or ascorbyl tetraisopalmitate
3. Subjects who are medically unfit
4. Pregnant subjects or those attempting to become pregnant
5. Subjects with known immunosuppression or immunosuppressive illness
6. Subjects with known sensitivity to ingredients in the test treatment products
7. Subjects having open wounds or sutures not removed
8. Subjects having no visible scars
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the clinical safety, efficacy, and performance of the SILCONEX scar treatment gel by performing a set of scar assessment tests (VSS, MSS, and POSAS) <br/ ><br>The below claimed efficacies of the product will be assessed during the study - <br/ ><br>1. Reduction in the redness of the scar <br/ ><br>2. Balance of skin tone by lightening the discoloured scar <br/ ><br>3.Maintenance of skin moisture 4.Softening of the scar <br/ ><br>5.Flattening of the raised scar <br/ ><br>6.Relieve discomfort and pain of the scar <br/ ><br>7.Early prevention of keloid and hypertrophic scar formation.Timepoint: 6 months <br/ ><br>Based on the previous research on silicone-based gels, results have demonstrated that the gel is used over 3 months and improvements can be seen between 3 to 6 months.
- Secondary Outcome Measures
Name Time Method To assess any emerging undesirable events along with monitoring of desired events, contraindications, residual risk, and emerging risk under normal usage of the SILCONEX scar treatment gel a for prolonged period to ensure acceptability of benefit-risk ratio of the SILCONEX scar treatment gelTimepoint: 6 months <br/ ><br>Based on the previous research on silicone-based gels, results have demonstrated that the gel is used over 3 months and improvements can be seen between 3 to 6 months.