Study for effectiveness and safety of skin lightening cream in dark spots

Phase 2

Completed

• Registration Number: CTRI/2011/091/000115
• Lead Sponsor: PIERRE FABRE DERMOCOSMETIQUE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1. Female aged between 18 and 50 years,

2. Subjects with phototypes III to VI,

3. Subjects with epidermal melasma of the face (bilateral hyperpigmented spots) graded moderate to severe (Grade 2 and 3 of the Static PGA)

4. For women of child bearing potential:

- negative urine pregnancy test at inclusion

- using an efficient contraceptive (condoms, implants, combined oral contraceptives, some intra-uterine devices, tubal ligature, sexual abstinence or vasectomised partner related to note 3 of the CPMP/ICH/286/95) for at least 8 weeks before the study and one month after the end of the study or using an oral contraceptive with more than 30μg of ethinyl-estradiol or progestative one, it having to be started since more than 12 weeks and until the end of the study.

5. Subject accepting to participate to the study and able to understand (linguistic and psychiatric),date and sign an approved Informed Consent Form and able to complete the subject diary

6. Subject able to understand the protocol and to come to the evaluation visits,

7. Subject who, in the judgement of the investigator is likely to be compliant during the study

8. Subject agreeing to use for epidermal melasma only the study products and no other treatment(s)/product(s)during the study duration

Exclusion Criteria

Subjects with dark spots on their face other than epidermal melasma, (as there will be difficulty in
standardization and difficulty in evaluation due to lack of standard assessment tools and questionnaires for
these dark spots).
? Subjects with dermal melasma
? Subject with other skin disorder on the face which could interfere with the evaluation (mycose, intertrigo),
? Acute or chronic systemic disease or disorder liable to interfere with the study product metabolism and/or
study implementation and/or study parameter assessment.
? Treatment by depigmenting cosmetic products applied to the face within the previous 4 weeks,
? Treatment by depigmenting treatment containing hydroquinone or any depigmenting product (e.g. topical
retinoids, topical steroids, ?) applied to the face within the previous 8 weeks,
? Previous treatment by chemical peels, laser treatments, dermabrasions, applied to the face with in previous 3
months
? Hypersensitivity, allergy or intolerance to hydroquinone or any component of the formulation,
Treatment by photosensitive agents within the previous 8 weeks,
? Subject who has planned to stay for more than 7 days in an area with an important increase in sun exposure
conditions compared to her usual place of residence during the study,
? Female who is pregnant or breast feeding or planning to become pregnant,
? Participation to an other clinical trial in the previous month or during the study,
? Past history of major medical, psychiatric disease or surgery which, in the judgment of the investigator , could
jeopardize their health or likely to modify their handling of the study product
? Subject who, in the judgement of the investigator, is not likely to be non-compliant during the study,
? Subject who has forfeited her freedom by administrative or legal decision, or who is under guardianship.

Study & Design

• Study Type: Interventional
• Study Design: Not specified