A Multi-Center, Randomized, Blinded, Split-Face, Controlled Clinical Study to Assess Two Targeted Brightening Serum (A and B) Paired With 4% Hydroquinone
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Measurement of Clinical Efficacy Parameters by Clinical Grader
Study Overview
Brief Summary
This a short four-week pilot study to measure the efficacy and tolerance of two brightening serums (cosmetics) versus 4% hydroquinone. The study was conducted in two sites across the USA, one in PA and in one in CA. The goal was to run the pilot study in the summer to understand the role of these two potential brightening serums in helping the appearance of skin tone evenness.
Detailed Description
This is a four-week multi-center, single-blind, randomized, split-face, controlled pilot study conducted to assess the efficacy and tolerance of two pigment correction formulations (Brightening Serum A and Brightening Serum B) compared to 4% Hydroquinone split face when used over the course of 4 weeks by healthy females with clinically determined mild to severe facial hyperpigmentation, including melasma on the global face. Subjects will be randomized into 2 cells which will receive the following split face treatments:
- Cell 1: Brightening Serum A versus 4% Hydroquinone
- Cell 2: Brightening Serum B versus 4% Hydroquinone It was hypothesized that the Brightening Serum A and B will produce statistically significant improvements at post-baseline timepoints when compared with baseline, and comparable improvements versus the standard of care 4% Hydroquinone across the primary endpoint, secondary and tertiary endpoints. Additionally, the Sponsor's test materials will be well tolerated by subjects, with no statistically significant increases in scores for tolerability/safety parameters, specifically erythema and dryness, at any study timepoint when compared with baseline scores. Furthermore, the Sponsor's test materials will be well perceived by subjects according to analyses of self-assessment questionnaires, with a statistically significant proportion of favorable responses compared to unfavorable responses and/or a statistically significant improvement in subject response values when compared with baseline.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
- Brightening Serum A and Brightening Serum B will be packaged in a 1.7 oz white airless package and labelled "Brightening Serum A" / "Brightening Serum B".
- The 4% Hydroquinone will be packaged in the designated package from the pharmacy.
- The study products will be dispensed/administered by clinic personnel other than the evaluator(s)/ investigator (board-certified dermatologist). Additionally, staff in charge of study product dispensation/administration and subjects will be instructed not to discuss study products with the Investigator or other evaluator(s).
- The randomization list will be secured in a cabinet and/or computer file accessible to a data committee consisting of selected representatives from the testing facility.
- Investigators will be blinded to the treatment of each patient. The investigators will not be allowed to review the products used by the patients.
- The products will be labeled with "R" Right or "L" Left to indicate facial side of application per random
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
- •Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type)
- •Age 20 to 60 years.
- •Subjects with self-perceived hyperpigmented facial skin
- •Having mild to severe (score of 3-9 according to a modified Griffiths scale,2 where 0 = none, 1 to 3 = mild, 4 to 6 = moderate, 7 to 9 = severe) full-face hyperpigmentation, including melasma. Hyperpigmentation and melasma must present at equal severity and size on each facial side.
- •Willing to maintain visit 1/baseline condition of eyebrows and eyelashes (do not noticeably change brow/lash appearance) during the study.
- •Willing to provide written informed consent and able to read, speak, write, and understand English.
- •Willing to sign a photography release.
- •Having not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox®), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin. Waxing and threading are allowed but not facial laser hair removal.
Exclusion Criteria
- •Having been diagnosed with known allergies to skin care products.
- •Having a known reactivity to tranexamic acid, niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, yeast, ascorbic acid, tetrahexyldecyl ascorbate, and/or any of the ingredients in the study products.
- •Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
- •Having a history of skin cancer within the past 5 years.
- •Currently taking oral or topical prescription medications for melasma such as Triluma, compounded hydroquinone, retinoids, and tranexamic acid.
- •Currently using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, bactrim, tetracycline, erythromycin, vibramycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.
Arms & Interventions
Brightening Serum B
The brightening serum B is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamic acid, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Intervention: Facial Cleanser (Other)
4% Hydroquinone
This topical 4% hydroquinone cream was applied split-face to side randomized for application.
Intervention: Facial Moisturizer (Other)
Brightening Serum A
The brightening serum A is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamoyl Dipeptide-23, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Intervention: Facial Cleanser (Other)
Brightening Serum A
The brightening serum A is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamoyl Dipeptide-23, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Intervention: Facial Moisturizer (Other)
Brightening Serum A
The brightening serum A is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamoyl Dipeptide-23, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Intervention: Sunscreen SPF 55 (Other)
Brightening Serum B
The brightening serum B is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamic acid, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Intervention: Facial Moisturizer (Other)
Brightening Serum B
The brightening serum B is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamic acid, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Intervention: Sunscreen SPF 55 (Other)
4% Hydroquinone
This topical 4% hydroquinone cream was applied split-face to side randomized for application.
Intervention: Facial Cleanser (Other)
4% Hydroquinone
This topical 4% hydroquinone cream was applied split-face to side randomized for application.
Intervention: Sunscreen SPF 55 (Other)
Outcomes
Primary Outcomes
Measurement of Clinical Efficacy Parameters by Clinical Grader
Time Frame: Baseline, week 2, week 4
Clinical grading efficacy parameters measured by blinded clinical grader including skin tone evenness, hyperpigmentation on the global face, and overall appearance. Grading was performed on a 10-point Griffith's scale, where 0 = best possible outcome 9= severe skin condition. A decrease in score/ value indicates an improvement.
Secondary Outcomes
- Measurement of Global Melasma Severity Assessment Score (GMSA)(baseline and weeks 2 and 4)