A 16-week Clinical Study Investigating a Dark Spot Corrector Serum in Women With Moderate Discrete Hyperpigmentation

A Single-Center, Randomized, Double-Blind, Controlled Clinical Study to Assess a Targeted Dark Spot Treatment Alongside 2 Different Skincare Regimens

This was a single-center, double-blinded, randomized, controlled cosmetic clinical trial to investigate the efficacy and tolerance of dark spot corrector serum and regimen skincare products when used over the course of 16 weeks by women with clinically determined moderate discrete hyperpigmentation (solar lentigines [age spots/sun spots]) on the global face, and self-perceived very bothersome hyperpigmentation (darkening), including spots, on the global face.

Study Overview

• Status: Completed
• Conditions: Hyperpigmentation; Dark Spots
• Intervention / Treatment: Other: Cosmetic dark spot corrector serum

Detailed Description

This was a single-center, double-blinded, randomized, controlled cosmetic clinical trial to investigate the efficacy and tolerance of dark spot corrector serum and regimen skincare products when used over the course of 12 weeks (spot treatment applied twice daily) and an additional 4-week maintenance period (spot treatment applied once daily) by women with clinically determined moderate discrete hyperpigmentation (solar lentigines [age spots/sun spots]) on the global face, and self-perceived very bothersome hyperpigmentation (darkening), including spots, on the global face.

Subjects were randomized to either the basic skincare regimen or the enhanced skincare regimen. Both cells tested the dark spot corrector serum. This is a new hydroquinone-free serum formulated to address hyperpigmentation (melasma, solar lentigines, post-inflammatory hyperpigmentation). The basic regimen comprised of the basic gentle foaming cleanser, the dark spot corrector serum, a basic moisturizer and sunscreen. The enhanced skincare regimen comprised of the sponsors skincare products including a 0.25% retinol night cream, a 30% vitamin C serum, and a tinted sunscreen moisturizer.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • SGS Dallas Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

2. In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.

3. Having Fitzpatrick skin type I-IV (refer to Appendix I: Fitzpatrick Skin Type).

4. Having moderate (score of 4-6 according to a modified Griffiths scale,1 where 0=none and 9=severe) discrete hyperpigmentation (solar lentigines [age spots/sun spots]) on the global face.

5. Having at least 1 dark spot (solar lentigo [age spot or sun spot]) with moderate intensity (score 4-6) on each side of the face (with no more 0.5 point difference between scores on each side of the face) that is at least 3 mm in size and clearly discernible by the clinical grader and visible in all images at baseline to be tracked as target spots during the study.

6. Self-perceived very bothersome hyperpigmentation (darkening), including spots, on the global face.

Exclusion Criteria:

1. Having been diagnosed with known allergies to skin care products.
2. Having a known reactivity to niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, and/or yeast.
3. Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
4. Having a history of skin cancer within the past 5 years.
5. Currently using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, Bactrim, tetracycline, erythromycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basic Skincare Regimen; Gentle foaming Cleanser - This was administered in white airless bottle labeled "Foaming Cleanser". The patient was to use this product in the morning and evening to cleanse their face. The patient was to pump 1 to 2x and wash their face with warm water and gently dry their face. Daily Moisturizer - This was administered as a white 3 oz tube labeled "daily moisturizer". Patients applied this product after their experimental product, the pigment corrector. Sunscreen SPF 50 Neutrogena - The clinical study site wrapped this product in duct tape and labelled as Sunscreen SPF 50. Patients were to use this product as their last step in their routine in the morning. They were asked to follow FDA guidelines of reapplication every 2 hours and if they were in direct sunlight.	Other: Cosmetic dark spot corrector serum; The dark spot correcting serum is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Experimental: Enhanced Skincare Regimen; Gentle foaming Cleanser - White airless bottle labeled "Foaming Cleanser". The patient was to use this product in the morning and evening to cleanse their face. The patient was to pump 1 to 2x and wash their face with warm water and gently dry their face. Vitamin C (30%) Serum -Product wrapped in duct tape and labelled this product Vitamin C Serum. Patients applied 1-2 pumps of the Vitamin C Serum to the entire face, avoiding the eye area after application of the Dark Spot Corrector. Application was morning and evening. Tinted Sunscreen SPF 45. Product wrapped in duct tape and labelled as Tinted Sunscreen SPF 45. Patients were to use this product as their last step in their routine in the morning. They were asked to follow FDA guidelines of reapplication every 2 hours and if they were in direct sunlight. This was applied after the Vitamin C Serum. Night Moisturizer with 0.25% Retinol - Apply 1-2 pumps of the Night Moisturizer to the entire face, avoiding the eye area.	Other: Cosmetic dark spot corrector serum; The dark spot correcting serum is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 and discrete hyperpigmentation (age spots/sun spots) on the global face; and for dark spot intensity (visual), dark spot size (visual), and dark spot appearance on each target dark spot. 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, 4, 8, 12, and 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 8, 12, 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Statistics for Self-assessment Questionnaires for Skin Conditions	At baseline and weeks 2, 4, and 12, subjects completed a Sponsor-provided self-assessment questionnaire. Subjects reviewed each statement and circled the following: Completely Agree (5), Slightly Agree (4), Neither Agree or Disagree (3), Slightly Disagree (2), Completely Disagree (1). An improvement from baseline conditions is expected for both the basic skincare regimen and enhanced skincare regimen.	At baseline and weeks 2, 4, and 12

Collaborators and Investigators

• Sponsor: Revision Skincare

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): March 13, 2025
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: dark spot correction; cosmetic skincare; brightening regimen
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Skin and Connective Tissue Diseases; Hyperpigmentation
• Other Study ID Numbers: C24-D117; Funded by Organization (Other Identifier: Revision Skincare)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No