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

NCT05013801 | Completed

• 1 other identifier: SKN-SFF-3469
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Melasma

Keywords

face

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in evenness of skin tone

  0 - 12 weeks + regression (8 weeks)

• Change in visual skin glow

  0 - 12 weeks + regression (8 weeks)

Other Outcomes (1)

• Change in perception of melasma as assessed using MelasQOL

  0 - 12 weeks + regression (8 weeks)

Study Arms (2)

Cosmetic Facial Serum Q69

EXPERIMENTAL

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

Other: Cosmetic facial serum Q69

2% Hydroquinone

OTHER

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

Interventions

Cosmetic facial serum Q69 OTHER

Cosmetic facial serum

Cosmetic Facial Serum Q69

2% Hydroquinone DRUG

2% Hydroquinone cream

2% Hydroquinone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unilever R&D: lead
• Shanghai Skin Disease and Venereal Disease Hospital: collaborator

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Melanosis; Facies

Interventions

hydroquinone

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yimei Tan, MD

  Shanghai Skin Disease Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 19, 2021
• Study Start: September 6, 2021
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)