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Periorbital WrinklesPhase 3NCT05082766

Improvement in the Appearance of Periorbital Wrinkles

A Phase 3 study testing enhanced DefenAge 8-in-1 BioSerum in people with Periorbital Wrinkles, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 31 years and olderHealthy volunteers can take part
Conditions the study is for
Periorbital Wrinkles
What is being tested?
enhanced DefenAge 8-in-1 BioSerum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
11 Oct 2021to 1 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 31 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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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  • 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)

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Sherif Mikhail, MD contact

8586571004

SMikhail@CLDerm.com

United States1 site, 1 recruiting

  • West Dermatology Research Center/Cosmetic Laser Dermatology

    San Diego, California, 92121

    Andrea Pacheco, 858-657-1004 ext. 143, apacheco@clderm.com

    Sherif Mikhail, MD, 858 657 1004, smikhail@westderm.com

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
enhanced DefenAge 8-in-1 BioSerum
Keywords
wrinkles, crow's feet, face wrinkles, face, cosmetic
Medical subject headings
Facies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • enhanced DefenAge 8-in-1 BioSerumDrug

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

Study groups in NCT05082766
Study groupRoleWhat they receive
DefenAge 8-in-1 BioSerum supplemented with enhanced concentration of defensinsExperimentalEnrolled subjects will all receive enhanced DefenAge 8-in-1 BioSerum to be applied on the face including periorbital area.
Receives: Drug: enhanced DefenAge 8-in-1 BioSerum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: baseline, Day 30, Day 60, and Day 90

  2. 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

    Measured: Day 30, Day 60, and Day 90

Secondary outcomes (4)

  1. 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)

    Measured: Day 30, 60 and 90

  2. 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)

    Measured: Day 30, 60 and 90

  3. Investigator assessment of tolerability of study drug including erythema, burning/stinging, dryness, peeling (desquamation), and tenderness

    Investigator assessment of tolerability of study drug

    Measured: Day 30, 60 and 90.

  4. Patient questionnaire

    Self-Assessment questionnaire

    Measured: Day 30, 60 and 90.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start11 Oct 2021
  3. Primary completion11 Oct 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
will be treated with the enhanced DefenAge 8-in-1 BioSerum to their entire face
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05082766
Sponsor's protocol ID
DefenAge-2021-01
Status last verified
Oct 2021
First submitted
24 Sep 2021
Last updated
28 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Possibly Efficacy Data-endpoints

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.

    PubMed 29601620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing enhanced DefenAge 8-in-1 BioSerum in people with Periorbital Wrinkles, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sherif Mikhail, MD (8586571004, SMikhail@CLDerm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician evaluator assessment of change using Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale (time frame: baseline, Day 30, Day 60, and Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05082766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.

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