Eficacy and safety study of drug that contains Pycnogenol which is used to treat spot on the ski

Phase 3

• Conditions: Melasma.Chloasma; L81.1; C17.800.621.430.530

• Registration Number: RBR-4phm6k
• Lead Sponsor: Medcin Instituto da Pele

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

100 participants; age range 25-65 years old; female; fitzpatrick skin types II and III;
patients with facial melasma; without any other cutaneous disease; without previous reaction to topical product; the patient should agree with the study-related procedures and the determinated days and time of appointments; Reading; understanding; agreement and signature of patient on the written informed free consent form.

Exclusion Criteria

Pregnancy; lactation; hormonal therapy within the last 4 weeks; use of photosensitizing drug; any melasma treatment in the same time;intensive solar exposure within the last 15 days and during the study; cutaneous marks on the experimental area that might interfere with cutaneous reaction evaluation; use of corticoide until 30 days before the selection and during the study;endocrine dysfunction; use of cosmetic products that might cause any facial irritation , even if it is mild such as exfoliating and antiaging products; other conditions that may be considered by doctors as a reason for disqualification of patient’s participation in the study

Study & Design

• Study Type: Intervention
• Study Design: Not specified