Clinical trial NCT05423873: 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
Official title: A Multi-Center Clinical Trial to Evaluate the Efficacy and Tolerability for Treatment of Facial Hyperpigmentation and Photodamaged Skin With a Dual Regimen Treatment Containing Vitamin C and a Tinted SPF 45 Moisturizer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperpigmentation
Photodamaged Skin
Wrinkle
Fine Lines
Keywords: Vitamin C
Sunscreen
Pollution
Solar Radiation
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 33
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in clinical efficacy of hyperpigmentation versus Baseline
timeFrame: 12 weeks
measure: Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline
timeFrame: 12 weeks
measure: Incidence and severity of adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement in clinical efficacy of photodamage versus Baseline
timeFrame: 12 weeks
measure: Lack of Significant Increase in Objective Subject Tolerability Parameters at week 4, 8, 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: Greenwood Village
country: United States
facility: About Skin
state: Colorado
city: Nashville
country: United States
facility: Brian S. Biesman, M.D.
state: Tennessee
Study officials:
References: