Improvement in the Appearance of Periorbital Wrinkles

Improvement in the Appearance of Periorbital Wrinkles With DefenAge 8-in-1 BioSerum Supplemented With Enhanced Concentration of Defensins

The primary objective of this study is to evaluate the efficacy of DefenAge 8-in-1 BioSerum supplemented with the enhanced concentration of defensins (enhanced 8-in-1 BioSerum) in the improvement of periorbital wrinkles.

Study Overview

• Status: Recruiting
• Conditions: Periorbital Wrinkles
• Intervention / Treatment: Drug: enhanced DefenAge 8-in-1 BioSerum

Detailed Description

Enrolled subjects will all receive enhanced DefenAge 8-in-1 BioSerum to be applied on the face including periorbital area.

Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory photography using Canfield Vectra 3D and VISIA. Patients will return for follow-up assessments at Day 30, 60, and 90.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • West Dermatology Research Center/Cosmetic Laser Dermatology
      • Principal Investigator: Sabrina Fabi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects in general good health greater than 30 years of age
• Must be willing and capable of giving consent and signing an Informed Consent Form
• Subjects with moderate to severe periorbital wrinkles (at least a grade II in wrinkles and score of 4 in elastosis on the Fitzpatrick-Goldman wrinkle scale)

• Female Subjects will be either of non-childbearing potential defined as:

  1. Having no uterus
  2. No menses for at least 12 months
  3. Bilateral tubal ligation Or; (WOCBP) women of childbearing potential, must have had a regular menstrual cycle prior to study entry. All systemic birth control measures must be in consistent use at least 6 months prior to study participation. WOCBP must agree to use an effective method of birth control during the course of the study, such as:
  1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
  2. Intrauterine coil
  3. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
  4. Abstinence or same sex partner (If practicing abstinence or sexual activity with a same sex partner, must agree to use barrier method described above (c) if becomes sexually active with a non-vasectomized male partner).
  5. Vasectomized male partner (for at least 6 months) (must agree to use barrier method described above (c) if becomes sexually active with un-vasectomized male partner).
• Negative urine pregnancy test results at Baseline prior to study entry (if applicable)

Exclusion Criteria:

• History of sensitivity to any ingredient in DefenAge 8-in-1 BioSerum.
• Subjects receiving any topical cosmetic anti-wrinkle and/or skin lightening products known to affect skin aging such as products containing hydroquinone, vitamin A derivatives (retinol, tretinoin, adapalene, tazarotene), alpha/beta/poly-hydroxy acids (salicylic acid, glycolic acid etc.), vitamins C or D (includes derivatives thereof), arbutin, retinol, azelaic acid, kojic acid, licorice extracts, bearberry extracts, mequinol) on the treatment area within 14 days prior to or during the study period, other than the study product.
• Subjects using any topical imiquimod, 5-fluorouracil, or diclofenac on their face within 12 weeks prior to or during the study period
• Subjects who have had a microdermabrasion (light or medium skin peel on their face within 30 days prior to or during the study period
• Subjects receiving a chemical peel, a non-ablative laser, light, radiofrequency, or ultrasound treatment on their face must have discontinued the drug/treatment at least 3 months prior to entering the study
• Subjects receiving Dermabrasion (deep skin peel) and/or ablative laser treatments on their face, and systemic retinoids must have discontinued the drug/treatment at least 6 months prior to entering the study
• History of or the presence of any skin condition/disease that might, in the opinion of the investigator, interfere with the diagnosis or evaluation of study parameters (i.e., acne, atopic dermatitis, eczema, psoriasis, seborrheic dermatitis)
• Subjects with current actinic keratoses or any other skin cancer(s) in the treatment areas
• Subjects with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
• Subjects with any active systemic disease that is not yet deemed medically stabilized
• Subjects with an active bacterial, fungal, or viral infection
• Subjects participating or completing participation in a clinical trial within 30 days prior to or during the study period
• A female subject who is currently breast-feeding, nursing, pregnant or planning to becoming pregnant during the study period
• Subjects not willing to comply with study dosing and complete the entire course of the study
• Subjects not willing to avoid extended periods of sun exposure for the duration of the study (including tanning beds). During the study, when excessive sun exposure is unavoidable, subjects should wear appropriate protective clothing and use the dispersed sunscreen

• Subjects who have had treatment with neuromodulators (ex. Botox, Dysport, or Xeomin) anywhere on the face within 6 months prior to or during the study period.

  18. Subjects who have had treatment with fillers anywhere on the face, or other forms of facial soft tissue augmentation (ex. Fat transfer) within 6 months prior to or during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DefenAge 8-in-1 BioSerum supplemented with enhanced concentration of defensins; Enrolled subjects will all receive enhanced DefenAge 8-in-1 BioSerum to be applied on the face including periorbital area.	Drug: enhanced DefenAge 8-in-1 BioSerum; DefenAge is a topical skincare brand containing a composition of biologically active natural molecules, named defensins, that repair skin damage associated with aging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician evaluator assessment of change using Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale	measurements will be completed based on images captured at baseline, Day 30, Day 60, and Day 90 and assessed by a blinded evaluator using the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale where wrinkling ranges from class 1 (fine wrinkles) to class 3 (Fine to deep wrinkles, numerous lines, with or without redundant skin folds) and Elastosis ranges from 1-3 (mild) to 7-9 (severe)	baseline, Day 30, Day 60, and Day 90
Asses the change of Percent of improvement at different time points	Percent improvement in periorbital wrinkles, laxity, pigmentation, erythema, texture, and radiance conducted by an evaluator	Day 30, Day 60, and Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-assessed Global Aesthetic Improvement Score (I-GAIS)	Investigator-assessed Global Aesthetic Improvement Score based on photographs where scale is 1 (much improved) to 5 (much worse)	Day 30, 60 and 90
Subject Global Aesthetic Improvement Score (S-GAIS)	Subject Global Aesthetic Improvement Score Day 30, 60 and 90 using photographs where scale is 1 (much improved) to 5 (much worse)	Day 30, 60 and 90
Investigator assessment of tolerability of study drug including erythema, burning/stinging, dryness, peeling (desquamation), and tenderness	Investigator assessment of tolerability of study drug	Day 30, 60 and 90.
Patient questionnaire	Self-Assessment questionnaire	Day 30, 60 and 90.

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: Advanced Dermatology; MediCell Technologies, LLC
• Investigators: Principal Investigator: Sabrina G Fabi, MD, Cosmetic Laser Dermatology

Publications and helpful links

General Publications

• Taub A, Bucay V, Keller G, Williams J, Mehregan D. Multi-Center, Double-Blind, Vehicle-Controlled Clinical Trial of an Alpha and Beta Defensin-Containing Anti-Aging Skin Care Regimen With Clinical, Histopathologic, Immunohistochemical, Photographic, and Ultrasound Evaluation. J Drugs Dermatol. 2018 Apr 1;17(4):426-441.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Anticipated): October 11, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: wrinkles; face; cosmetic; crow's feet; face wrinkles
• Other Study ID Numbers: DefenAge-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Possibly Efficacy Data-endpoints

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No