An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream

NCT04911374 | Completed

• 1 other identifier: C20-D134
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.

Conditions

Wrinkle; Photoaging; Fine Lines

Outcome Measures

Primary Outcomes (2)

• Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks 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. 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

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

  The primary tolerability endpoint will be 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: 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 (4)

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

  12 weeks

• Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline

  12 weeks

• Stable skin pH during 12 week study

  12 weeks

• Improvement in Epidermal Thickness after 12 weeks versus baseline

  12 weeks

Other Outcomes (1)

• Self-Assessment Questionnaire

  12 weeks

Study Arms (1)

Anti-Aging Face Moisturizer and Eye Cream

OTHER

Dual Regimen: 1. Multi-ingredient anti-aging face moisturizer 2. Multi-ingredient anti-aging eye cream

Other: Gentle Cleansing Lotion, Revision Skincare; Other: Aveeno Face Milk SPF 40+

Interventions

Gentle Cleansing Lotion, Revision Skincare OTHER

Gentle cleansing lotion to be used by study participants

Anti-Aging Face Moisturizer and Eye Cream

Aveeno Face Milk SPF 40+ OTHER

Sunscreen to be applied after application of face moisturizer and eye cream in the morning. Participants were asked to apply the sunscreen if sun exposure was more than 30 minutes per day.

Anti-Aging Face Moisturizer and Eye Cream

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between the ages of 35 and 65 years
• Women with Fitzpatrick skin type I-VI
• Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate 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 had any invasive or non-invasive skin treatments, or invasive medical procedures three months prior to the study
• Subjects that are unwilling to comply with the protocol
• Female subjects who are pregnant, breast feeding, or planning a pregnancy.
• 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.

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (1)

Stephens and Associates

Richardson, Texas, 75081, United States

Location

Study Design

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

Model Details: Open-label study. 45 female subjects recruited, 35 to 65 years, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 3, 2021
• Study Start: September 11, 2020
• Primary Completion: December 22, 2020
• Study Completion: February 3, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

US (1)