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

Revision Skincare

Status: Completed

Conditions: Hyperpigmentation; Dark Spots

Treatments: Other: Cosmetic dark spot corrector serum

Study type: Interventional

Funder types: Industry

Identifiers

NCT07468175

Funded by Organization (Other Identifier)

C24-D117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Basic Skincare Regimen

Experimental group

Description:

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.

Treatment:

Other: Cosmetic dark spot corrector serum

Enhanced Skincare Regimen

Experimental group

Description:

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.

Treatment:

Other: Cosmetic dark spot corrector serum