MedPath

To study the safety and effectiveness of LASER treatment

Phase 2
Completed
Registration Number
CTRI/2023/09/057734
Lead Sponsor
Mr. Antonius Soelistyo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

1.Female subject between 30-55 years of age.

2.Subjects of Fitzpatrick skin types III to V based on ITA (10 to 45) for the respective phototype.

3.Subjects with textural imperfections that may require skin rejuvenation will be selected based on the expert discretions

4.Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.

5.Subject who agrees not to use any other product/treatment/home remedy/soap bar on their face during the study period.

6.Subject to agree not to carry out bleaching or any other procedures on face during the study period.

7.Subject to agree to remove all jewellery etc. during assessments.

8.Subjects willing to give a voluntary written informed consent and agree to come for regular follow up.

9.Subjects willing to abide by and comply with the study protocol.

10.Subjects who have not participated in a similar investigation in past four weeks.

11.Subjects who are willing not to participate in any other clinical study during participation in the current study.

Exclusion Criteria

1.Subject with any other signs of significant local irritation or skin disease.

2.Subjects who are regular users of anti-aging serum or have not used similar serums in the last one month

3.Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.

4.Subject having chronic illness or had major surgery in the last year.

5.Subjects undergoing any treatment of any skin condition.

6.Subjects not willing to discontinue other topical skin care products until completion of the study.

7.Subject allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.

8.Subject pregnant or nursing.

9.Subjects with any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Significant improvement in skin brightness, color and texture by visual skin assessment using MSCR scale in comparison to baseline. <br/ ><br>2.Significant improvement in skin color and reduction in pores using Antera in comparison to baseline. <br/ ><br>3.Significant improvement in skin elasticity and firmness using Cutometer in comparison to baseline. <br/ ><br>4.Significant improvement in skin texture using Visioscan, Antera and Cherry imaging in comparison to baseline <br/ ><br>5.Significant improvement in skin attributes using VISIA CR in comparison to baselineTimepoint: Visit-1, Visit-2, Visit-3, Visit-4
Secondary Outcome Measures
NameTimeMethod
Significant reduction in wrinkles using Cherry imaging in comparison to baselineTimepoint: Visit-1, Visit-2, Visit-3, Visit-4
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