Effect of the SCAR CLEARING GEL to treat Scars.

Phase 3

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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.
Subject is having apparently healthy skin without any open wounds, cuts, abrasions, irritation symptoms on test area.
Subjects willing to give voluntary written informed consent.
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.

Exclusion Criteria

Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
Subjects diagnosed with scleroderma.
Subjects with any kind of skin allergy or cutaneous disease which may influence the study results.
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.
Hypersensitivity to any of the ingredients of the test product.
Pregnant or lactating women 9.
Patients on steroid therapy or any other immunomodulatory agents.

Primary Outcome Measures

Name	Time	Method
-Mexameter (Marked scar)- pre and post study	DAy 0,DAy 30 and Day 60
-Cutometer (Marked scar)- pre and post study	DAy 0,DAy 30 and Day 60
1.Instrumental Assessmentâ€“	DAy 0,DAy 30 and Day 60
2. Vas Scar scoring	DAy 0,DAy 30 and Day 60
3. Skin moisture	DAy 0,DAy 30 and Day 60
4. Skin brightening	DAy 0,DAy 30 and Day 60
5. Skin smoothening	DAy 0,DAy 30 and Day 60

Secondary Outcome Measures

Name	Time	Method
Outcome TimePoints	Patient and Investigator Feedbacks will be obtained

Locations (1): Brindas Skin Clinic
🇮🇳
Pondicherry, PONDICHERRY, India
Brindas Skin Clinic
🇮🇳Pondicherry, PONDICHERRY, India
Dr Brinda G David
Principal investigator
9751628254
docbrinz@gmail.com