To study "Quality of Life" and untoward effects of TRI-LUMA Cream in women with melasma on face.

Phase 4

Completed

Conditions: with moderate to severe melasma on the face

Registration Number: CTRI/2018/01/011403

Lead Sponsor: Galderma India Private Limited

Brief Summary: At theend of study,

Based on **ParticipantQuality of life questionnaire and Satisfaction questionnaire** it can beconcluded that Test Product: TRI-LUMA Cream - Batch No.: GF01 used along withCetaphil Daylong SPF 50+ PA+++ Light Gel - B. No: V132

**Helped in improving the Quality of Life for melasma condition which wasagreed upon by more than 90% of participants.**

**More than 50% of participants were overall satisfied with the treatment**

Based on **Instrumentalevaluation**

**Significant reduction in amount of melanin present on the facial skin**

**Significant lightening of pigmented area**

Based on **Non-invasiveUltrasound biomicroscopy**

**Significant reduction in Epidermal entry echo**

**Significant reduction in skin thickness**

**Significant reduction in Subepidermal Hypoechoic band thickness**

Based on **Clinicalevaluation**

**Significant reduction in melasma**

Based on **clinicaland subjective self-evaluation**

TRI-LUMA Cream was very well tolerated by allparticipants

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 35

Inclusion Criteria

Participants with moderate to severe melasma on the face.
Childbearing potential patient with highly effective contraceptive methods Willing to avoid unusual sun exposure as far as possible for the entire study duration.

Exclusion Criteria

Patients with prior history of mometasone based triple combination melasma therapy or under hormonal replacement therapy including usage of OC pills If Patients were immunocompromised or were under immunosuppressive treatment, or had contraindications for corticosteroid treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life and Participant Satisfaction	Day 0, 1 month, 2 months

Secondary Outcome Measures

Name	Time	Method
Clinical evaluation of skin atrophy	Day 0, 1 month, 2 months
Non-invasive Ultrasound biomicroscopy (UBM) of the skin	Day 0, 1 month, 2 months
Clinical evaluation for in use tolerance	Day 0, 1 month, 2 months
Subjective self-assessment for in use tolerance	Day 0, 1 month, 2 months
Percent Changes in MASI score	Day 0, 1 month, 2 months
Instrumental evaluation for color	Day 0, 1 month, 2 months

Trial Locations

Locations (1): C.L.A.I.M.S. PVT.LTD
🇮🇳
Mumbai, MAHARASHTRA, India
C.L.A.I.M.S. PVT.LTD
🇮🇳Mumbai, MAHARASHTRA, India
Dr Rajiv Joshi
Principal investigator
22-66758851
rsjd@rediffmail.com