Back to results

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

Primary Purpose

Melasma

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Cosmetic facial serum Q69

2% Hydroquinone

About this trial

This is an interventional treatment trial for Melasma focused on measuring face

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts 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

Sites / Locations

Shanghai Skin Disease Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cosmetic Facial Serum Q69

2% Hydroquinone

Arm Description

Cosmetic facial serum. To be used twice daily on lesional areas of the face for 12 weeks.

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.

Outcomes

Primary Outcome Measures

Change in L*

CIELAB colour space L* (perceptual lightness), measured using Konica Minolta CM-2600d portable spectrophotometer

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.

Secondary Outcome Measures

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

Change in visual skin glow

Composite parameter calculated using output from CM2600d and VISIA-CR

Full Information

NCT ID

NCT05013801

First Posted

August 13, 2021

Last Updated

October 31, 2022

Sponsor

Unilever R&D

Collaborators

Shanghai Skin Disease and Venereal Disease Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05013801

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

September 6, 2021 (Actual)

Primary Completion Date

February 25, 2022 (Actual)

Study Completion Date

February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unilever R&D

Collaborators

Shanghai Skin Disease and Venereal Disease Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melasma

Keywords

face

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cosmetic Facial Serum Q69

Arm Type

Experimental

Arm Description

Cosmetic facial serum. To be used twice daily on lesional areas of the face for 12 weeks.

Arm Title

2% Hydroquinone

Arm Type

Other

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Cosmetic facial serum Q69

Intervention Description

Cosmetic facial serum

Intervention Type

Drug

Intervention Name(s)

2% Hydroquinone

Intervention Description

2% Hydroquinone cream

Primary Outcome Measure Information:

Title

Change in L*

Description

CIELAB colour space L* (perceptual lightness), measured using Konica Minolta CM-2600d portable spectrophotometer

Time Frame

0 - 12 weeks + regression (8 weeks)

Title

Change in modified Melasma Area Severity Index (mMASI)

Description

Time Frame

0 - 12 weeks + regression (8 weeks)

Secondary Outcome Measure Information:

Title

Change in evenness of skin tone

Description

Evenness of skin tone as assessed through analysis of images captured using the Canfield Scientific VISIA-CR imaging system

Time Frame

0 - 12 weeks + regression (8 weeks)

Title

Change in visual skin glow

Description

Composite parameter calculated using output from CM2600d and VISIA-CR

Time Frame

0 - 12 weeks + regression (8 weeks)

Other Pre-specified Outcome Measures:

Title

Change in perception of melasma as assessed using MelasQOL

Description

Quality of life questionnaire specifically developed for use with melasma

Time Frame

0 - 12 weeks + regression (8 weeks)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yimei Tan, MD

Organizational Affiliation

Shanghai Skin Disease Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Skin Disease Hospital

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs