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

Part of paid clinical trials in Richardson, Texas.

Sponsor
Revision Skincare
Study ID
NCT07468175
Status
Completed

Conditions

  • Dark Spots
  • Hyperpigmentation

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 65 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Oct 21, 2024
Status verified
Mar 2026
Primary completion
Mar 13, 2025
Completion
Mar 27, 2025

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Measurement of Clinical Efficacy Parameters by Clinical Grader [ Time Frame: Baseline, week 2, 4, 8, 12, and 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
SGS Dallas Research CenterRichardsonTexas75081-

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By research site
SGS Dallas Research Center· Richardson, TX

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