An interventional study of Cosmetic facial serum Q69 and 2% Hydroquinone in Melasma, sponsored by Unilever R&D. Completed at 1 site in China. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by Unilever R&D · Not applicable, Interventional, and Treatment
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
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).
149 studies on the registry are indexed under Melanosis; 38 are open to participants now.
This study's enrollment of 96 is above the median of 40 across 139 interventional studies indexed under Melanosis.
Browse Melanosis studies →Unilever R&D is the lead sponsor of 69 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cosmetic facial serum. To be used twice daily on lesional areas of the face for 12 weeks.
Other: Cosmetic facial serum Q69
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
Cosmetic facial serum
2% Hydroquinone cream
Change in L*
CIELAB colour space L\* (perceptual lightness), measured using Konica Minolta CM-2600d portable spectrophotometer
Time frame: 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.
Time frame: 0 - 12 weeks + regression (8 weeks)
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
Time frame: 0 - 12 weeks + regression (8 weeks)
Change in visual skin glow
Composite parameter calculated using output from CM2600d and VISIA-CR
Time frame: 0 - 12 weeks + regression (8 weeks)
Change in perception of melasma as assessed using MelasQOL
Quality of life questionnaire specifically developed for use with melasma
Time frame: 0 - 12 weeks + regression (8 weeks)
Plan to share: No
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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