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Not yet recruitingNCT07216352Updated Oct 28, 2025

Evaluate the Safety and Efficacy of a Topical Serum (AGE Serum) in Improving Visible Signs of Aging

An interventional study of AGE Serum in Laxity; Skin, sponsored by Goldman, Butterwick, Fitzpatrick and Groff. Not yet recruiting at 1 site in United States. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-28.

Sponsored by Goldman, Butterwick, Fitzpatrick and Groff · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
25 Years to 50 Years
Sex
All
01

Study summary

The primary objective is to evaluate the safety and efficacy of a topical serum (AGE serum) in improving visible signs of aging (e.g., fine lines, wrinkles, sagging, texture, radiance) on the full face and neck.The study will be conducted in non-menopausal female and male subjects who are on glucagon-like peptide-1 (GLP-1) agonist therapy for weight loss.

Read the detailed description

enrolled subjects will apply a topical serum (AGE Serum) to the full face and neck twice daily for 12 weeks. Subject follow-up visits will occur at Week 6 and Week 12. Subjects will complete assessments and participate in and standardized 2D and 3D (Visia) digital photography.

02

Conditions studied

  • Laxity; Skin

Keywords

  • glp1
  • weight loss
  • skin laxity
  • skin texture
  • skin tone
03

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Presence of mild to moderate signs of facial aging (e.g., fine lines, laxity, dull texture) based on modified Griffith scale.
  2. Adult men and women aged 25-50 years.
  3. Fitzpatrick skin types I-IV.
  4. Current treatment with a stable dose of GLP-1 agonist medication, including Ozempic, Rybelsus, or Wegovy for at least last 6 months.
  5. Must be willing to sign a photography release and ICF, and complete the entire course of the study.
  6. Subjects in good general health based on the investigator's judgment and medical history.
  7. Negative urine pregnancy test result at the time of study entry (if applicable).
  8. Subjects of childbearing potential must agree to use an effective method of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.

A. Acceptable forms of birth control are: oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device/coil, double-barrier methods (e.g., sponge, spermicide, or condoms). Abstinence and/or vasectomized partners must agree to a second acceptable method of birth control (double-barrier) should the subject become sexually active.

B. A female is considered of non-childbearing potential if she is: postmenopausal (no menses for at least 12 months), without a uterus (hysterectomy) and/or both ovaries (oophorectomy), or bilateral tubal ligation.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy or planned pregnancy during the study or currently breastfeeding.
  2. Current menopausal state.
  3. Any uncontrolled systemic disease.
  4. Current use of other GLP-1 agonist therapy aside from the GLP-1 agonist class of medications (Ozempic, Rybelsus, or Wegovy).
  5. History of autoimmune connective tissue disease.
  6. Current use of immunosuppressive medication.
  7. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
  8. Active dermatitis or active infection in the proposed treatment area.
  9. Mesotherapy; dermal fillers, biostimulator injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery during the 12-month period before study treatment.
  10. Creams/cosmeceuticals and/or home therapies for the prevention or treatment of skin quality in the treatment area during the 1-month period before study treatment.
  11. Subjects with scarring in the treatment areas, which in the opinion of the investigator could impact results. Subjects with a history of keloids will be excluded.
  12. Subjects who spray tanned or used sunless tanners in the treatment areas 1-month prior to study treatment.
  13. History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease (e.g., lupus, scleroderma), history of Bell's Palsy, epilepsy, smoking, and/or current pregnancy or breastfeeding.
  14. Inability to ambulate following the procedure.
  15. History of lidocaine and/or epinephrine sensitivity deemed by the investigator to preclude subject from enrolling into study.
  16. Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study.
  17. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    AGE Product

    Enrolled subjects will received AGE Serum.

    Other: AGE Serum

Interventions

  • OtherAGE Serum

    AGE serum is a topical that contains a high concentration of 30% Proxylane and a synergistic blend of fruit-derived flavonoids (blueberry, pomegranate) and Cassia alata extract.

05

What researchers measure

Primary outcomes

  1. Modified Griffith Scale

    Modified Griffiths 10-point scale to be used for investigator grading of cutaneous signs of photoaging on the face. Global Fine Lines. Scale 0 (no fine lines) to 9 (numerous, many fine lines) Overall Hyperpigmentation: Scale 0 (no hyperpigmentation) to 9 (significant hyperpigmentation) Skin Tone Eveness: Scale 0 (very even tone) to 9 (uneven, discolored appearance) Skin Elasticity: Score 0 (skin feels toned and dense) to 9 (skin feels thin and flabby) Skin Firmness: Score 0 (firm, tight feeling) to 9 (loose, lax feeling) Skin Radiance: Score 0 (very radiant, luminous, glowing) to 9 (very dull) Skin Texture: Score 0 (very smooth) to 9 (very rough)

    Time frame: Baseline, Week 6 and Week12

Secondary outcomes

  1. Physician Global Aesthetic Improvement Scale

    Physician Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse

    Time frame: Week 12

  2. Subject Global Aesthetic Improvement Scale

    Subject Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse

    Time frame: Week 12

  3. Subject Self-Assessment Questionnaire

    Circle One Skin Feels More Comfortable: Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly Skin Appears Younger Looking: Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly Skin Appears Healthier: Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly Skin Looks Renewed/Revitalized: Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly Skin Looks Firmer: Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly Skin Feels Elastic : Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly Redness Looks Reduced: Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly

    Time frame: Baseline, Week 6 and Week 12

06

Study locations

1 site
  • West Dermatology Research Center
    San Diego, California 92121, United States
    • Andrea Pacheco · Contact · apacheco@clderm.com · 858-657-1004
    • Freia Canals-Cistero · Contact · 858-657-1004
07

Registry details

Key details

Study ID
NCT07216352
Lead sponsor
Goldman, Butterwick, Fitzpatrick and Groff
Collaborators
L'Oreal
Responsible party
Sponsor
First posted
Oct 14, 2025
Start date
Oct 25, 2025 (estimated)
Primary completion
Mar 30, 2026 (estimated)
Completion
May 30, 2026 (estimated)
Last update
Oct 28, 2025

Study contacts

Andrea Paccheco
Contact
apacheco@clderm.com
858-657-1004

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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