A Clinical Study to Evaluate the Effect of Facial Serum Q69 in Moderating the Appearance of Mild to Moderate Melasma

Unilever

Status

Completed

Conditions

Melasma

Treatments

Drug: 2% Hydroquinone

Other: Cosmetic facial serum Q69

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05013801

SKN-SFF-3469

Details and patient eligibility

About

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

Full description

This is a single blind (outcomes assessor), randomized, 2 cell, full face study to evaluate changes in mild malar melasma through use of a cosmetic facial serum formulation or marketed 2% hydroquinone. This study will accept up to fifty participants per cell (100 participants overall) who meet the inclusion/exclusion criteria to ensure that at least forty participants per cell complete the study. Participants will be randomized to receive either the cosmetic product or the hydroquinone product.

The study schedule will be different depending which product the subject is allocated to.

If accepted onto the study, all participants will be provided with a marketed face wash and moisturiser to use for one week before the baseline visit.

At the baseline visit, following collection of baseline measures subjects will be allocated to either the cosmetic product or 2% hydroquinone. Products will be applied only to lesional areas on the face twice daily. Participants will also be provided with a sunscreen for use throughout the test phase of the study. They will continue to use the face wash and moisturiser with which they have previously been provided.

Participants allocated to the cosmetic product will be asked to return to the study centre for assessments at weeks 4, 8, 12 and regression (8 weeks after stopping product application).

Participants allocated to 2% hydroquinone will be asked to return to the study centre 3 days, 1, 2, 4, 6 and 8 weeks after baseline and regression 8 weeks after stopping product application).

Enrollment

96 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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