A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines

Revision Skincare56 enrolled

Overview

This randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face. Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. Self-assessment questionnaires and VISIA photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be performed at baseline, weeks 8 and 12. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fine Lines Wrinkles Photoaging

Interventions

Facial cleanserCOMBINATION_PRODUCT

Facial cleanser to be used by study participants

Facial moisturizerCOMBINATION_PRODUCT

Bland moisturizer to be used by study participants after serum in the evening.

SunscreenCOMBINATION_PRODUCT

Sunscreen to be applied after application of serum in the morning.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women between the ages of 35 and 60 years were scheduled for eligibility screening at the study site. * Women with Fitzpatrick Skin Type I-VI * Subjects must have mild to moderate global face wrinkles and fine lines * Subjects may have mild to moderate photo-aging secondary to physiologic aging * 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: * Female subjects who are pregnant, breast feeding, or planning a pregnancy. * Subjects with severe overall photo damage as determined by the Investigator. * Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin. * Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. * Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator. * Subjects who spend excessive time out in the sun. * Subjects who are unwilling or unable to comply with the requirements of the protocol.

Locations (1)

Ablon Skin Institute Research Center

Manhattan Beach, California, United States

Outcomes

Primary Outcomes

Clinical Efficacy Graded by Griffiths' Scale

The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 28, Day 56 and Day 84 in comparison to baseline indicates an improvement for the indicated parameter.The efficacy parameters will be assessed globally 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.

Time frame: 12 weeks

Objective Tolerability: scores

The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A decrease in scores or lack of significant increase at Day 28, Day 56 and Day 84 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

Time frame: 12 weeks

Secondary Outcomes

Subjective Tolerability: scores

The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A decrease in scores or lack of significant increase at Day 28, Day 56 and Day 84 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example Burning. 0 = None No burning of the treatment area 1. = Mild Slight burning sensation of the treatment area; not really bothersome 2. = Moderate Definite warm, burning of the treatment area that is somewhat bothersome. 3. = Severe Hot burning sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep

Time frame: 12 weeks

Data from ClinicalTrials.gov

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