Investigator Initiated Study (IIS)

Not Applicable

Completed

• Conditions: Health Condition 1: L819- Disorder of pigmentation, unspecified

• Registration Number: CTRI/2018/11/016267
• Lead Sponsor: CUTIS Academy of Cutaneous Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-20
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Female patients, between 18-45 years of age, with epidermal hyperpigmentation.

2.Participants able to provide a written informed consent

2.Participants willing to follow up for three visits over a period of 12 weeks (approximately).

3.Participants able and willing to follow all the study procedures including abstinence from usage of any OTC product related to face applications.

3.Participants willing to be clinically photographed as per protocol

Exclusion Criteria

1.Patient not willing to participate in the study or comply with any study procedures / requirements.

2.Patients using other pigment reduction creams.

3.Patients with other dermatological disorder of the face that may interfere with the study evaluation (Acne, Dermatosis Papulosa Nigra (DPN), Melasma, Seborrheic melanosis)

4.Patients with known hypersensitivity to any of the study drugs or constituents.

5.Patients expected to be exposed to the triggering factors during the course of study. (excessive sun exposure, UVB photo therapy, use of oral contraceptive pills (OCPs)

6.Patient who received facial procedures like dermabrasion, chemical peels or laser procedures within the last 1 month.

7.History of or ongoing thyroid disorder

8.Any patient as per investigatorâ??s opinion is unfit for participation in the study.

9.Pregnant / lactating females

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect assessed in terms of reduction in epidermal pigmentation assessed clinically, dermoscopically and by using Fotofinder.Timepoint: After 3 months of using the product

Secondary Outcome Measures

Name	Time	Method
1.Patients satisfaction with treatment will be assessed based on a Grading questionnaire <br/ ><br>2.Safety will be assessed based on the ADR reported during the study period. <br/ ><br>3.Patient compliance will be assessed based on completed patient diary and compliance assessment during study visitsTimepoint: after 3 months of using the product