CTRI/2023/04/051466
Not yet recruiting
未知
A Prospective Study on Safety and Effectiveness in Softening, Lightening, and Flattening Raised Scars while Maintaining Skin Moisture and Relieving Discomfort.
ENNOGEN Healthcare International Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ENNOGEN Healthcare International Limited
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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