A Multi-Center, Open-label Study Evaluate the Efficacy and Tolerability of a Dual Skincare Regimen Treatment for Facial Hyperpigmentation and Photodamaged Skin in Patients Exposed to Extrinsic Factors of Aging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2022-02-10

Brief Summary

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This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage after 12 weeks of twice daily use in healthy female subjects between 35 - 60 years old. A total of 33 subjects completed study participation.

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Detailed Description

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This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage when used twice daily over the course of 12 weeks by healthy women with Fitzpatrick skin type I - V, moderate to severe global face hyperpigmentation and moderate global face photodamage.

Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for hyperpigmentation (mottled), hyperpigmentation (discrete), overall photodamage, clarity/brightness, overall appearance, skin tone evenness (redness), fine lines and wrinkles. Investigator and subject tolerability, self-assessment questionnaire and clinical VISIA photography will be completed at baseline, weeks 4, 8 and 12. Subject testimonials will be completed at week 12.

A total of 33 subjects completed study participation.

Conditions

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Hyperpigmentation Photodamaged Skin Wrinkle Fine Lines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, Multi-Center, Open-Label 33 female subjects between 35 to 60 years old with Fitzpatrick skin type I-V, moderate to severe global face hyperpigmentation, and moderate global face photodamage.

Washout period of 2 weeks refraining from active antiaging topical products, including vitamin C, retinoids, peptides, and growth factors.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vitamin C Serum and Moisturizing Sunscreen SPF 45

Dual Regimen:

Vitamin C Serum Tinted Moisturizing Sunscreen SPF 45

Group Type OTHER

Gentle Cleansing Lotion, Revision Skincare

Intervention Type OTHER

Gentle cleansing lotion to be used by study participants twice daily

Interventions

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Gentle Cleansing Lotion, Revision Skincare

Gentle cleansing lotion to be used by study participants twice daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women between the ages of 35 and 60 years old.
* Women with Fitzpatrick skin type I-V.
* Subjects must have moderate to severe global face hyperpigmentation.
* Subjects must have moderate global face photodamage.
* Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
* Subjects must be willing to provide verbal understanding and written informed consent.

Exclusion Criteria

* Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face.
* Subjects that are unwilling to comply with the protocol.
* Female subjects who are pregnant, breast feeding, or planning a pregnancy.
* Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
* Subjects who have a history of skin cancer.
* Subjects who have observable suntan, sunburn, scars, nevi, tattoo, excess hair, etc. or other dermatological condition on the face that might influence the test results in the opinion of the investigator.
* Subjects who have routinely used any anti-aging, anti-wrinkles, antioxidants treatments and skin-firming products less than 30 days prior to the study entry.

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes