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

NCT ID: NCT04545970

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2020-07-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fine Lines Wrinkles Photoaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Randomization will occur by assignment to either the active group or placebo group using a randomization table prepared prior to the start of the study by a non-participating staff member at the office of the investigator. Subjects will be assigned a number in numerical order as enrolled. The unblinded staff member will take a set of products from one of two groups of labeled active product vs. placebo and fill in the patient number and distribution date on the bottles to be dispensed to the subject.

Study Groups

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Anti-aging Serum

Dosage form: Serum composed of water, thickener, and bioactive ingredients including antioxidants and peptides.

Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening.

Study Duration: 12 weeks.

Group Type ACTIVE_COMPARATOR

Facial cleanser

Intervention Type COMBINATION_PRODUCT

Facial cleanser to be used by study participants

Facial moisturizer

Intervention Type COMBINATION_PRODUCT

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

Sunscreen

Intervention Type COMBINATION_PRODUCT

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

Placebo Serum

Dosage form: Serum composed of water and thickener. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening.

Study Duration: 12 weeks.

Group Type PLACEBO_COMPARATOR

Facial cleanser

Intervention Type COMBINATION_PRODUCT

Facial cleanser to be used by study participants

Facial moisturizer

Intervention Type COMBINATION_PRODUCT

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

Sunscreen

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Facial cleanser

Facial cleanser to be used by study participants

Intervention Type COMBINATION_PRODUCT

Facial moisturizer

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

Intervention Type COMBINATION_PRODUCT

Sunscreen

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Neutrogena Sheer Zinc SPF 30

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ablon Skin Institute Research Center

OTHER

Sponsor Role collaborator

Revision Skincare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glynis Ablon, MD, FAAD

Role: PRINCIPAL_INVESTIGATOR

Ablon Skin Institute Research Center

Locations

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Ablon Skin Institute Research Center

Manhattan Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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ASIRC-RS-01

Identifier Type: -

Identifier Source: org_study_id

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