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To study the safety and effectiveness of LASER treatment

A study to evaluate the efficacy of the Multifrax LASER device in providing skin rejuvenation by non-ablative skin resurfacing in skin of color patients - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057734
Enrollment
20
Registered
2023-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Multifrax LASER device: LASER treatment will be done for four times in approximately four months for improving skin attributes. Total study duration will be four months. Control Inter

Sponsors

Mr. Antonius Soelistyo
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1.Significant improvement in skin brightness, color and texture by visual skin assessment using MSCR scale in comparison to baseline. 2.Significant improvement in skin color and reduction in pores using Antera in comparison to baseline. 3.Significant improvement in skin elasticity and firmness using Cutometer in comparison to baseline. 4.Significant improvement in skin texture using Visioscan, Antera and Cherry imaging in comparison to baseline 5.Significant improvement in skin attributes using VISIA CR in comparison to baselineTimepoint: Visit-1, Visit-2, Visit-3, Visit-4

Secondary

MeasureTime frame
Significant reduction in wrinkles using Cherry imaging in comparison to baselineTimepoint: Visit-1, Visit-2, Visit-3, Visit-4

Countries

India

Contacts

Public ContactMukta Sachdev

MS Clinical Research Pvt Ltd

mukta.sachdev@msclinical.com08041125934

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026