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

NCT07216352 | Not Yet Recruiting

• 1 other identifier: AGE-SERUM-2025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laxity; Skin

Keywords

glp1; weight loss; skin laxity; skin texture; skin tone

Outcome Measures

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)

  Baseline, Week 6 and Week12

Secondary Outcomes (3)

• Physician Global Aesthetic Improvement Scale

  Week 12

• Subject Global Aesthetic Improvement Scale

  Week 12

• Subject Self-Assessment Questionnaire

  Baseline, Week 6 and Week 12

Study Arms (1)

AGE Product

EXPERIMENTAL

Enrolled subjects will received AGE Serum.

Other: AGE Serum

Interventions

AGE Serum OTHER

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.

AGE Product

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of mild to moderate signs of facial aging (e.g., fine lines, laxity, dull texture) based on modified Griffith scale.
• Adult men and women aged 25-50 years.
• Fitzpatrick skin types I-IV.
• Current treatment with a stable dose of GLP-1 agonist medication, including Ozempic, Rybelsus, or Wegovy for at least last 6 months.
• Must be willing to sign a photography release and ICF, and complete the entire course of the study.
• Subjects in good general health based on the investigator's judgment and medical history.
• Negative urine pregnancy test result at the time of study entry (if applicable).
• 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.

You may not qualify if:

• Pregnancy or planned pregnancy during the study or currently breastfeeding.
• Current menopausal state.
• Any uncontrolled systemic disease.
• Current use of other GLP-1 agonist therapy aside from the GLP-1 agonist class of medications (Ozempic, Rybelsus, or Wegovy).
• History of autoimmune connective tissue disease.
• Current use of immunosuppressive medication.
• Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• Active dermatitis or active infection in the proposed treatment area.
• 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.
• 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.
• 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.
• Subjects who spray tanned or used sunless tanners in the treatment areas 1-month prior to study treatment.
• 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.
• Inability to ambulate following the procedure.
• History of lidocaine and/or epinephrine sensitivity deemed by the investigator to preclude subject from enrolling into study.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• L'Oreal: collaborator

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Cutis Laxa; Weight Loss

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Paccheco

CONTACT

858-657-1004; apacheco@clderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All 25 adult subjects will be enrolled in to the same group and provided the same product.

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 14, 2025
• Study Start: October 25, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (1)