Improvement in the Appearance of Periorbital Wrinkles

Sponsor

Goldman, Butterwick, Fitzpatrick and Groff (Other)

Overall Status

Recruiting

CT.gov ID

NCT05082766

Collaborator

Advanced Dermatology (Other), MediCell Technologies, LLC (Other)

Enrollment

Location

Arm

13.7

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Periorbital Wrinkles	Drug: enhanced DefenAge 8-in-1 BioSerum	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

will be treated with the enhanced DefenAge 8-in-1 BioSerum to their entire facewill be treated with the enhanced DefenAge 8-in-1 BioSerum to their entire face

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 11, 2021

Anticipated Primary Completion Date :

Oct 11, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Clinician evaluator assessment of change using Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale [baseline, Day 30, Day 60, and Day 90]
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)
Asses the change of Percent of improvement at different time points [Day 30, Day 60, and Day 90]
Percent improvement in periorbital wrinkles, laxity, pigmentation, erythema, texture, and radiance conducted by an evaluator

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

31 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Having no uterus
No menses for at least 12 months
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:
Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
Intrauterine coil
Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
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).
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.

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.