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CompletedNCT07468175Updated Mar 12, 2026

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

An interventional study of Cosmetic dark spot corrector serum in Hyperpigmentation and Dark Spots, sponsored by Revision Skincare. Completed at 1 site in United States. Open to female participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Revision Skincare · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Oct 2024, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperpigmentation
  • Dark Spots

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Keywords

  • dark spot correction
  • cosmetic skincare
  • brightening regimen
03

In context

Hyperpigmentation

127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.

This study's enrollment of 48 is above the median of 32 across 113 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

Revision Skincare is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
48 participants (actual)

Study 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.

    Other: Cosmetic dark spot corrector serum

  • 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

Interventions

  • OtherCosmetic 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.

06

What researchers measure

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.

    Time frame: Baseline, week 2, 4, 8, 12, and 16

Secondary outcomes

  1. 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.

    Time frame: 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, 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.

    Time frame: At baseline and weeks 2, 4, and 12

07

Study locations

1 site
  • SGS Dallas Research Center
    Richardson, Texas 75081, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2024 to primary completion in Mar 2025, 4 months.

Of 27 industry-sponsored interventional studies with no phase under Hyperpigmentation, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 10. This study's 4 months is above that.

Counting every sponsor, half of 64 studies reached it within 7 months; a quarter within 3 and three quarters within 25.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2026
First posted
Mar 12, 2026
StartActual
Oct 21, 2024
Primary completionActual
Mar 13, 2025
CompletionActual
Mar 27, 2025
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07468175
Lead sponsor
Revision Skincare
Responsible party
Sponsor
First posted
Mar 12, 2026
Start date
Oct 21, 2024
Primary completion
Mar 13, 2025
Completion
Mar 27, 2025
Last update
Mar 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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