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

Evaluation of â??Quality of Lifeâ?? and in-use tolerance in women with facial melasma, after using a triple combination drug (TRI-LUMA Cream)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011403

Enrollment

Registered

2018-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Triple combination drug (TRI-LUMA Cream): Approximately 0.2 gms to be applied evenly to form a thin film on the affected area, once at night for 2 months Control Intervention1: Not Appl

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Quality of life and Participant SatisfactionTimepoint: Day 0, 1 month, 2 months	—

Secondary

Measure	Time frame
Clinical evaluation for in use toleranceTimepoint: Day 0, 1 month, 2 months;Clinical evaluation of skin atrophyTimepoint: Day 0, 1 month, 2 months;Instrumental evaluation for colorTimepoint: Day 0, 1 month, 2 months;Non-invasive Ultrasound biomicroscopy (UBM) of the skinTimepoint: Day 0, 1 month, 2 months;Percent Changes in MASI scoreTimepoint: Day 0, 1 month, 2 months;Subjective self-assessment for in use toleranceTimepoint: Day 0, 1 month, 2 months	—

Measure

Time frame

Clinical evaluation for in use toleranceTimepoint: Day 0, 1 month, 2 months;Clinical evaluation of skin atrophyTimepoint: Day 0, 1 month, 2 months;Instrumental evaluation for colorTimepoint: Day 0, 1 month, 2 months;Non-invasive Ultrasound biomicroscopy (UBM) of the skinTimepoint: Day 0, 1 month, 2 months;Percent Changes in MASI scoreTimepoint: Day 0, 1 month, 2 months;Subjective self-assessment for in use toleranceTimepoint: Day 0, 1 month, 2 months

—

Countries

India

Contacts

Public ContactDr Amanjit Kaur Ahluwalia

Galderma India Private Limited

Swapnil.DESHPANDE@galderma.com8691031041

Outcome results