Improvement in the Appearance of Periorbital Wrinkles

NCT ID: NCT05082766

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2022-12-01

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.

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.

Conditions

Periorbital Wrinkles

Keywords

wrinkles; crow's feet; face wrinkles; face; cosmetic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

enhanced DefenAge 8-in-1 BioSerum

Intervention Type: DRUG

DefenAge is a topical skincare brand containing a composition of biologically active natural molecules, named defensins, that repair skin damage associated with aging.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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:

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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.

• Minimum Eligible Age: 31 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Advanced Dermatology

OTHER

Sponsor Role: collaborator

MediCell Technologies, LLC

UNKNOWN

Sponsor Role: collaborator

Goldman, Butterwick, Fitzpatrick and Groff

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabrina G Fabi, MD

Role: PRINCIPAL_INVESTIGATOR

Cosmetic Laser Dermatology

Locations

West Dermatology Research Center/Cosmetic Laser Dermatology

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sherif Mikhail, MD

Role: CONTACT

Phone: 8586571004

Email: SMikhail@CLDerm.com

Facility Contacts

Andrea Pacheco

Role: primary

Sherif Mikhail, MD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 29601620 (View on PubMed)

Other Identifiers

DefenAge-2021-01

Identifier Type: -

Identifier Source: org_study_id