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

NCT05423873 | Completed

• 1 other identifier: RS-2020-04
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

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.

Conditions

Hyperpigmentation; Photodamaged Skin; Wrinkle; Fine Lines

Keywords

Vitamin C; Sunscreen; Pollution; Solar Radiation

Outcome Measures

Primary Outcomes (3)

• Improvement in clinical efficacy of hyperpigmentation versus Baseline

  The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A change in scores at week 4, week 8 and week 12 in comparison to baseline indicates an improvement for the indicated parameter. Global facial hyperpigmentation will be assessed on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome.

  12 weeks

• Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline

  The primary tolerability endpoint will be favorable analysis of the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A change in scores or lack of significant change at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example for Erythema: 0 = None No erythema of the treatment area, 1 = Mild Slight, but definite redness of the treatment area, 2 = Moderate Definite redness of the treatment area, 3 = Severe Marked redness of the treatment area

  12 weeks

• Incidence and severity of adverse events

  The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects through-out the length of the study.

  12 weeks

Secondary Outcomes (2)

• Improvement in clinical efficacy of photodamage versus Baseline

  12 weeks

• Lack of Significant Increase in Objective Subject Tolerability Parameters at week 4, 8, 12

  12 weeks

Study Arms (1)

Vitamin C Serum and Moisturizing Sunscreen SPF 45

OTHER

Dual Regimen: Vitamin C Serum Tinted Moisturizing Sunscreen SPF 45

Other: Gentle Cleansing Lotion, Revision Skincare

Interventions

Gentle Cleansing Lotion, Revision Skincare OTHER

Gentle cleansing lotion to be used by study participants twice daily

Vitamin C Serum and Moisturizing Sunscreen SPF 45

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (3)

Art of Skin MD

Solana Beach, California, 92075, United States

Location

About Skin

Greenwood Village, Colorado, 80111, United States

Location

Brian S. Biesman, M.D.

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Hooper D, Tedaldi R, Iglesia S, Young MB, Kononov T, Zahr AS. Antioxidant Skincare Treatment for Hyperpigmented and Photodamaged Skin: Multi-Center, Open-Label, Cross-Seasonal Case Study. J Clin Aesthet Dermatol. 2023 Oct;16(10):31-38.

  PMID: 37915337 DERIVED

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 21, 2022
• Study Start: March 17, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

US (3)