A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation
8 juni 2026 uppdaterad av: Revision Skincare
A Multi-Center, Randomized, Blinded, Split-Face, Controlled Clinical Study to Assess Two Targeted Brightening Serum (A and B) Paired With 4% Hydroquinone
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
18
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
-
Irving, Texas, Förenta staterna, 75063
- Revision Skincare
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
|
|
Aktiv komparator: 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.
|
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
|
|
Övrig: 4% Hydroquinone
This topical 4% hydroquinone cream was applied split-face to side randomized for application.
|
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measurement of Clinical Efficacy Parameters by Clinical Grader
Tidsram: 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.
|
Baseline, week 2, week 4
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measurement of Global Melasma Severity Assessment Score (GMSA)
Tidsram: baseline and weeks 2 and 4
|
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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measurement of facial Melasma
Tidsram: Baseline, week 2 and week 4
|
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
|
Baseline, week 2 and week 4
|
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Incidence of Treatment- Emergent Adverse Events
Tidsram: Baseline, week 2, and week 4
|
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
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 augusti 2025
Primärt slutförande (Faktisk)
12 november 2025
Avslutad studie (Faktisk)
12 november 2025
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 07242025
- Revision Skincare, LLC (Annat bidrag/finansieringsnummer: Revision Skincare, LLC)
Läkemedels- och apparatinformation, studiedokument
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