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

Wrinkle Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423873
• Other study ID #: RS-2020-04
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: June 2022
• Source: Revision Skincare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fine Lines
• Hyperpigmentation
• Photodamaged Skin
• Wrinkle

Intervention

Other:
• Gentle Cleansing Lotion, Revision Skincare
Gentle cleansing lotion to be used by study participants twice daily

Locations

Country	Name	City	State
United States	About Skin	Greenwood Village	Colorado
United States	Brian S. Biesman, M.D.	Nashville	Tennessee
United States	Art of Skin MD	Solana Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Revision Skincare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Improvement in clinical efficacy of photodamage versus Baseline	The secondary 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 photodamage 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
Secondary	Lack of Significant Increase in Objective Subject Tolerability Parameters at week 4, 8, 12	The primary tolerability endpoint will be favorable analysis of the Subject 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: 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