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

Revision Skincare

Status

Completed

Conditions

Fine Lines

Hyperpigmentation

Photodamaged Skin

Wrinkle

Treatments

Other: Gentle Cleansing Lotion, Revision Skincare

Study type

Interventional

Funder types

Industry

Identifiers

NCT05423873

RS-2020-04

Details and patient eligibility

About

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.

Full description

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.

Enrollment

33 patients

Sex

Female

Ages

35 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.