MelasmaNCT05013801
A Clinical Study to Evaluate the Effect of Facial Serum Q69 in Moderating the Appearance of Mild to Moderate Melasma
A study testing Cosmetic facial serum Q69 and 2% Hydroquinone in people with Melasma, run by Unilever R&D at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Cosmetic facial serum Q69 and 2% Hydroquinone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2021to 25 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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).
- Conditions
- Melasma
- Being tested
- Cosmetic facial serum Q69, 2% Hydroquinone
- Keywords
- face
- Medical subject headings
- Melanosis, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic facial serum Q69Other
Cosmetic facial serum
2% HydroquinoneDrug
2% Hydroquinone cream
| Study group | Role | What they receive |
|---|---|---|
| Cosmetic Facial Serum Q69 | Experimental | Cosmetic facial serum. To be used twice daily on lesional areas of the face for 12 weeks. Receives: 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. Receives: Drug: 2% Hydroquinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in L*
CIELAB colour space L* (perceptual lightness), measured using Konica Minolta CM-2600d portable spectrophotometer
Measured: 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.
Measured: 0 - 12 weeks + regression (8 weeks)
Secondary outcomes (2)
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
Measured: 0 - 12 weeks + regression (8 weeks)
Change in visual skin glow
Composite parameter calculated using output from CM2600d and VISIA-CR
Measured: 0 - 12 weeks + regression (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start6 Sep 2021
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Skin Disease and Venereal Disease Hospital
- Responsible party
- Sponsor
- Investigators
- Yimei Tan, MD, Principal investigator, Shanghai Skin Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013801
- Sponsor's protocol ID
- SKN-SFF-3469
- Status last verified
- Oct 2022
- First submitted
- 13 Aug 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05013801
- Acronym / sponsor ID
- SKN-SFF-3469
- Conditions
- Melasma
- Keywords
- face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Skin Disease and Venereal Disease Hospital
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cosmetic Facial Serum Q69 | Experimental | Other: Cosmetic facial serum Q69Cosmetic facial serum. To be used twice daily on lesional areas of the face for 12 weeks. |
| 2% Hydroquinone | Other | Drug: 2% Hydroquinone2% hydroquinone cream to be used twice daily on lesional areas of the face as directed by the dermatologist for no longer than 8 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic facial serum Q69Cosmetic facial serum | Other | Cosmetic Facial Serum Q69 |
| 2% Hydroquinone2% Hydroquinone cream | Drug | 2% Hydroquinone |
Primary outcome
Change in L*
Time frame: 0 - 12 weeks + regression (8 weeks)
CIELAB colour space L* (perceptual lightness), measured using Konica Minolta CM-2600d portable spectrophotometer
Change in modified Melasma Area Severity Index (mMASI)
Time frame: 0 - 12 weeks + regression (8 weeks)
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.
2 secondary outcomes
Change in evenness of skin tone
Time frame: 0 - 12 weeks + regression (8 weeks)
Change in visual skin glow
Time frame: 0 - 12 weeks + regression (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yimei Tan, MD principal investigator
Shanghai Skin Disease Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic facial serum Q69 and 2% Hydroquinone in people with Melasma, run by Unilever R&D at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in L* (time frame: 0 - 12 weeks + regression (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.