West Dermatology Research Center
San Diego, California, 92121, United States
NCT Number: NCT07216352
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.
Trial opening soon.
Get Notified25 year–50 year
All sexes
Interventional
Not applicable
San Diego, California, 92121, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Time frame: Baseline, Week 6 and Week12
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: Week 12
Physician Grading:
Time frame: Week 12
Subject Grading:
Time frame: Baseline, Week 6 and Week 12
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
Contact information is provided by the study sponsor or research team.
Goldman, Butterwick, Fitzpatrick and Groff
Other
Open-label Study Evaluating the Safety and Efficacy of AGE Serum in Non-menopausal Patients on Glucagon-like Peptide-1 Agonists
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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