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

NCT07468175 | Completed

• 2 other identifiers: C24-D117Funded by Organization
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperpigmentation; Dark Spots

Keywords

dark spot correction; cosmetic skincare; brightening regimen

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 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 Outcomes (1)

• Incidence of Treatment- Emergent Adverse Events

  Baseline, week 2, 8, 12, 16

Other Outcomes (1)

• Change From Baseline Statistics for Self-assessment Questionnaires for Skin Conditions

  At baseline and weeks 2, 4, and 12

Study Arms (2)

Basic Skincare Regimen

EXPERIMENTAL

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

Enhanced Skincare Regimen

EXPERIMENTAL

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

Interventions

Cosmetic dark spot corrector serum OTHER

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.

Basic Skincare Regimen; Enhanced Skincare Regimen

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: The study was conducted on biological women as this was part of inclusion criteria.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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-IV (refer to Appendix I: Fitzpatrick Skin Type).
• \. 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.
• \. 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.
• \. Self-perceived very bothersome hyperpigmentation (darkening), including spots, on the global face.

You may not qualify if:

• Having been diagnosed with known allergies to skin care products.
• Having a known reactivity to niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, and/or yeast.
• 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 using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, Bactrim, tetracycline, erythromycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (1)

SGS Dallas Research Center

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Model Details: This was a double-blinded, single-center controlled study. The interventional study model was performed in parallel. Subjects were randomized either to the basic skincare regimen or the enhanced skincare regimen. Both experimental cells had the intervention, dark spot corrector serum. The objective was to review clinical parameters for both cells at post-baseline timepoints versus baseline AND to review the basic skincare regimen versus the enhanced skincare regimen.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 12, 2026
• Study Start: October 21, 2024
• Primary Completion: March 13, 2025
• Study Completion: March 27, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)