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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2011/091/000115
• Date of registration: 27-01-2011
• Prospective Registration: Yes
• Primary sponsor: PIERRE FABRE DERMOCOSMETIQUE
• Public title: Study for effectiveness and safety of skin lightening cream in dark spots
• Scientific title: EFFICACY AND SAFETY OF SKIN LIGHTENING TOPICAL CREAM IN DARK SPOTS
• Date of first enrolment: 10-02-2011
• Target sample size: 90
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2632
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 2

Countries of recruitment

France, India, Mauritius

Contacts

• Name: Dr Sanjeev Miglani
• Affiliation: CIDP Biotech India Pvt. Ltd.

• Name: Rashi Nangia
• Affiliation: CIDP Biotech India Pvt. Ltd.

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Skin Lightening Cream: 2 phalanxes Unit, on a half-face, daily
Control Intervention1: Placebo: 2 phalanxes Unit, on a half-face, daily

Primary Outcome(s)

To assess comparatively the efficacy of skin lightening cream versus vehicle after 12 weeks (D84) topical

daily application by clinical score: Dynamic PGA (Physician Global Assessment)Timepoint: Visit 2 (day 28 ± 4): evaluation visit

Visit 3 (day 56+4): evaluation visit

Visit 4 (day 84 ± 8): end of study visit

Secondary Outcome(s)

To assess comparatively the efficacy of skin lightening cream versus vehicle by clinical scores :
- Static PGA (4-8-12 weeks topical daily applications)
- Dynamic PGA (4-8 weeks topical daily applications)
- Melasma Area Severity Index (MASI) (4-8-12 weeks topical daily applications)
- Modified MASI (4-8-12 weeks topical daily applications)
? To assess the tolerance of the cutaneous cream.
? To assess the efficacy of the product by Subject autoevaluation. (Subject global efficacy assessment: the
subject will be asked to choose the half of the face where the improvement of melasma seems the best).
? To assess the efficacy by Investigator global assessment (the investigator will be asked to choose the subject
half of the face were the improvement of melasma seems the best).
? To assess the Quality of life by MelasQoL (13)
? To assess by digital standardised photo (visible and UV light) the efficacy of a skin lightening cream to reduce
size and intensity of the dark spots(expert cotation)
? To assess by colorimetric evaluation the efficacy of the skin lightening cream to reduce the darkness of the
dark spots.Timepoint: Visit 1 (day 1): Inclusion visit
Visit 2 (day 28 ± 4): evaluation visit
Visit 3 (day 56+4): evaluation visit
Visit 4 (day 84 ± 8): end of study visit

Secondary ID(s)

RV4280A 2011 5, Version 1, 10 Jan 2011

Source(s) of Monetary Support

PIERRE FABRE DERMOCOSMETIQUE 45, Place Abel Gance F-92100 Boulogne France

Secondary Sponsor(s)

CIDP Biotech India Pvt Ltd

Ethics review

Status: Approved
Approval date: 24/01/2011
Contact:

Norms Ethical Committee-Mangalore