A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation

NCT07644871 | Completed

• 2 other identifiers: 07242025Revision Skincare, LLC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpigmentation; Melasma; Dark Spots

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Measurement of Global Melasma Severity Assessment Score (GMSA)

  baseline and weeks 2 and 4

Other Outcomes (2)

• Measurement of facial Melasma

  Baseline, week 2 and week 4

• Incidence of Treatment- Emergent Adverse Events

  Baseline, week 2, and week 4

Study Arms (3)

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.

Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen SPF 55

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.

Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen SPF 55

4% Hydroquinone

OTHER

This topical 4% hydroquinone cream was applied split-face to side randomized for application.

Other: Facial Cleanser; Other: Facial Moisturizer; Other: Sunscreen SPF 55

Interventions

Facial Cleanser OTHER

Gentle Foaming Cleanser to wash the face two times a day (am/pm)

4% Hydroquinone; Brightening Serum A; Brightening Serum B

Facial Moisturizer OTHER

Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).

4% Hydroquinone; Brightening Serum A; Brightening Serum B

Sunscreen SPF 55 OTHER

Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step

4% Hydroquinone; Brightening Serum A; Brightening Serum B

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: We only recruited females with mild to severe hyperpigmentation which includes melasma. Melasma is more common in women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (1)

Revision Skincare

Irving, Texas, 75063, United States

Location

MeSH Terms

Conditions

Hyperpigmentation; Melanosis

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: * 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 12, 2026
• Study Start: August 11, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)