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

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

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

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Other: Cosmetic facial serum Q69; Drug: 2% Hydroquinone

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Skin Disease Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cosmetic Facial Serum Q69; Cosmetic facial serum. To be used twice daily on lesional areas of the face for 12 weeks.	Other: Cosmetic facial serum Q69; Cosmetic facial serum
Other: 2% Hydroquinone; 2% hydroquinone cream to be used twice daily on lesional areas of the face as directed by the dermatologist for no longer than 8 weeks.	Drug: 2% Hydroquinone; 2% Hydroquinone cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in L*	CIELAB colour space L* (perceptual lightness), measured using Konica Minolta CM-2600d portable spectrophotometer	0 - 12 weeks + regression (8 weeks)
Change in modified Melasma Area Severity Index (mMASI)	Melasma severity on four facial areas (forehead, right malar region, left malar region and chin) is assessed based on three variables: percentage of the total area involved (A), darkness (D), and homogeneity (H). Area (A): a numerical value is assigned to % area involved as follows. 0=no involvement; 1=<10% ; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; and 6=90-100%. Darkness of melasma (D) is graded on a scale of 0 to 4: 0=normal skin color without evidence of hyperpigmentation; 1=barely visible hyperpigmentation; 2=mild hyperpigmentation; 3=moderate hyperpigmentation; 4=severe hyperpigmentation. Homogeneity of hyperpigmentation (H) is graded on a scale of 0 to 4 as follows: 0=normal skin color without evidence of hyperpigmentation; 1=specks; 2=small patchy areas <1.5 cm diameter; 3= >2 cm diameter; 4=uniform skin involvement without any clear areas. The sum of D and H is multiplied by A and by the percentages of the four facial areas (10-30%). Total score is 0-48.	0 - 12 weeks + regression (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in evenness of skin tone	Evenness of skin tone as assessed through analysis of images captured using the Canfield Scientific VISIA-CR imaging system	0 - 12 weeks + regression (8 weeks)
Change in visual skin glow	Composite parameter calculated using output from CM2600d and VISIA-CR	0 - 12 weeks + regression (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perception of melasma as assessed using MelasQOL	Quality of life questionnaire specifically developed for use with melasma	0 - 12 weeks + regression (8 weeks)

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Shanghai Skin Disease and Venereal Disease Hospital
• Investigators: Principal Investigator: Yimei Tan, MD, Shanghai Skin Disease Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): February 25, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: face
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Radiation-Protective Agents; Hydroquinone
• Other Study ID Numbers: SKN-SFF-3469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No