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

NCT04545970 | Completed

• 1 other identifier: ASIRC-RS-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fine Lines; Wrinkles; Photoaging

Keywords

anti-aging; serum

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  12 weeks

Secondary Outcomes (2)

• Subjective Tolerability: scores

  12 weeks

• Self Assessment Questions

  12 weeks

Study Arms (2)

Anti-aging Serum

ACTIVE COMPARATOR

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.

Combination Product: Facial cleanser; Combination Product: Facial moisturizer; Combination Product: Sunscreen

Placebo Serum

PLACEBO COMPARATOR

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.

Combination Product: Facial cleanser; Combination Product: Facial moisturizer; Combination Product: Sunscreen

Interventions

Facial cleanser COMBINATION_PRODUCT

Facial cleanser to be used by study participants

Anti-aging Serum; Placebo Serum

Facial moisturizer COMBINATION_PRODUCT

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

Anti-aging Serum; Placebo Serum

Sunscreen COMBINATION_PRODUCT

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

Also known as: Neutrogena Sheer Zinc SPF 30

Anti-aging Serum; Placebo Serum

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revision Skincare: lead
• Ablon Skin Institute Research Center: collaborator

Study Sites (1)

Ablon Skin Institute Research Center

Manhattan Beach, California, 90266, United States

Location

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Officials

• Glynis Ablon, MD, FAAD

  Ablon Skin Institute Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 11, 2020
• Study Start: December 23, 2019
• Primary Completion: March 11, 2020
• Study Completion: July 6, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)