A clinical trial to Evaluate Efficacy and Safety of AG Arbutin Cream in Skin Lightening (Melanin Reduction) In Healthy Subjects.

Double blind, Randomized, Placebo Controlled Single Center, Prospective Study to Evaluate Efficacy and Safety of AG Arbutin Cream in Skin Lightening (Melanin Reduction) In Healthy Subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000731

Enrollment

Registered

2009-09-24

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: AG Arbutin cream: 0.2 gm bd for 4 weeks Control Intervention1: Placebo cream: 0.2 gm bd for 4 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male and female subjects (based on medical history and general examination) within 18 ? 55 years of age 2. Healthy subjects with no prior history of skin disease or skin related problems in past six months 3. Subjects willing to give written informed consent and willing to follow up regularly for entire duration of the study

Exclusion criteria

Exclusion criteria: 1. Subjects who are on any medication for skin disorder or applying any topical medication (including cosmetic) to left forearm during the duration of study. 2. Pregnant and lactating females 3. Subjects receiving steroids, retinoids, non-steroidal anti-inflammatory drugs or any other drugs causing hyperpigmentation or used for the treatment of hyperpigmentation (Refer to Appendix A: Drugs causing hyperpigmentation & Drugs used for the treatment of hyperpigmentation) 4. Subject who has participated in any clinical trial in the past 4 weeks

Design outcomes

Primary

Measure	Time frame
Melanin assessmentTimepoint: Baseline, Week 2Â± 3 days, Wk 4Â± 3 days;Melanin assessmentTimepoint: Baseline, Week 2Â± 3 days, Wk 4Â± 3 days	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Ashish Adgaonkar

sujay.kulkarni@piramal.com02230818611

Outcome results