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| ID | Type | Description | Link |
|---|---|---|---|
| Revision Skincare, LLC | Other Grant/Funding Number | Revision Skincare, LLC |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brightening Serum A | Active Comparator | 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. |
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| Brightening Serum B | Active Comparator | 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. |
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| 4% Hydroquinone | Other | This topical 4% hydroquinone cream was applied split-face to side randomized for application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial Cleanser | Other | Gentle Foaming Cleanser to wash the face two times a day (am/pm) |
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| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Clinical Efficacy Parameters by Clinical Grader | 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. | Baseline, week 2, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Global Melasma Severity Assessment Score (GMSA) | The expert grader (Board-Certified Dermatologist) will evaluate the right and left facial side using a Global Melasma Severity Assessment (GMSA) according to the following numerical definitions. Half-point scores may be used as necessary to more accurately describe the skin condition. 0 = clear
| baseline and weeks 2 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of facial Melasma | The MASI score is a clinical tool used to assess the severity of melasma, a hyperpigmentation disorder, in terms of both area and darkness. It quantifies the extent and intensity of melasma in four facial regions: the forehead (F), right malar region (MR), left malar region (ML), and chin (C), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively. A decrease in score indicates improvement |
Inclusion Criteria:
Exclusion Criteria:
We only recruited females with mild to severe hyperpigmentation which includes melasma. Melasma is more common in women.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Revision Skincare | Irving | Texas | 75063 | United States |
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| Facial Moisturizer | Other | Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ). |
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| Sunscreen SPF 55 | Other | Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step |
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| Baseline, week 2 and week 4 |
| Incidence of Treatment- Emergent Adverse Events | Local cutaneous tolerability was evaluated by assessing the signs and symptoms of the following objective and subjective irritation parameters globally on each subject's face. Objective irritation (clinically graded): erythema, edema, and dryness. Subjective irritation (assessed by subjects): burning, stinging, and itching. Local cutaneous tolerability was evaluated by assessing objective (erythema, edema, and dryness) and subjective (burning, stinging, and itching) irritation parameters globally on each subject's face using a 4-point scale (0 = none to 3 = severe). A decrease in value indicates an improvement. | Baseline, week 2, and week 4 |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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