A Randomized, Controlled, Single Center Clinical Study to Evaluate the Effect of Facial Serum Q69 in Moderating the Appearance of Mild to Moderate Melasma

SKN-SFF-3469

This is a single centre, 2-cell, single blinded full-face (products applied at lesional sites) study to evaluate changes in melasma through a cosmetic facial serum formulation and marketed 2% Hydroquinone product

2021-09-06

2022-02-25

2022-02-25

Completed

96

Inclusion Criteria: * Participant in general good health as per the Medical History screening criteria * Female participants between 18-55 years of age at first study visit (both inclusive) * Participant having mild to moderate facial melasma * Participants having skin type II-IV * Participants with melasma pigmentation which has been stable for 3 months (self-reported) * Participants who are willing to dedicate time and follow the instructions as per the study protocol * Participants willing to give a voluntary written informed consent for activities in the study for imaging and agree to come for regular study visits Exclusion Criteria: * Participants are pregnant or anticipating pregnancy during the study period or are currently breast-feeding as self-reported * Participants with known allergies to facial skin care products including sunscreens, bar or liquid cleansing products, moisturizers/lotions, lightening/brightening products, antiaging products, adhesives, and/or fragrances * Participants who are consistently exposed to sunlight either through their work or habits, such as continuous exposure to sunlight that is more than 2 hours of duration. * Participants who have sunburn, suntan, scars, nevi, excessive hair, tattoos, birthmarks, or any other dermal conditions on the test sites that might influence the test results in the opinion of the Investigator * Participant with dry or scaly facial skin or with self-perceived pimple prone \&/or sensitive skin or with any other signs of significant local irritation * Participants having a history or currently having skin conditions such as eczema or psoriasis, severe acne, nodules, cyst, eczema, seborrheic dermatitis, severe excoriations on the face currently or in adult life * Participants allergic to sulphite containing drugs * Participants who have used any medication (including Hydroquinone, retinoids) in the last two 2 months for melasma treatment * Participants not tolerant to retinoids or Vitamin-A related medicines or products * Participants with a history of Asthma, Hypertension, diabetes, or any other illness that the Investigator deems inappropriate for participation or could interfere with the study outcome * Participants taking medication continuously/regularly every day such as corticosteroids or non-steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the study * Participants who are currently participating in any clinical study * Participants who have participated in any clinical trial involving the face in the past 8 weeks prior to inclusion into this study

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 96, 'type': 'ACTUAL'}}

2022-11-01