Skin Care Regimen for Improving Photoaging Signs on the Face

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Improve Photoaging Signs

In brief

Compare the effectiveness of laser treatment using CE Ferulic versus vehicle pre/post laser.

Key facts

Study ID: NCT06603857
Run by: Goldman, Butterwick, Fitzpatrick and Groff
People needed: 40
Starts: 2024-09-27
Expected to finish: 2025-02-28
Last updated by the study team: 2024-09-19

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult males and females aged 30-70 years (Fitzpatrick I-IV 30-65 years, Fitzpatrick V-VI 30-70 years)
Fitzpatrick skin types I-VI
Subjects in good general health based on investigator's judgment and medical history
Must be willing to give and sign an informed consent form and photographic release form
Must be willing to have examinations of face and digital photographs performed of the face
Physician evaluator classifying the subject as mild to moderate (Score 3-6) on the modified Griffiths 10-Point Scale for the face.
The subject must be planning to undergo fractional non-ablative laser resurfacing to the face and bilateral postauricular area and be willing to comply with study protocol and complete the entire course of the study.
Subjects using any treatment skincare products (per investigator discretion) must discontinue use of these products four weeks before the start of participating in this clinical study and for the duration of the study.
Male subjects with facial hair must be willing to shave prior to every visit.
Must be willing to maintain usual sun exposure
Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
Negative urine pregnancy test result at the time of study entry (if applicable)
For female subjects of childbearing potential, must be willing to use an acceptable form 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 female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
Must be willing to comply with study treatments and complete the entire course of the study

You may not qualify if…

Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area in the last 6 months
Chemical peel or microdermabrasion of the face within 60 days prior to enrollment in the study
Dermal fillers, biostimulators, or neurotoxins treatments of the face during the 6-month period before the study period or planning to undergo during the study period
Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction to the neck and/or submentum, etc.) during the 12-month period before study treatment
Any investigational treatment for improvement of skin quality and/or photodamage of facial skin during the 6-month period before the study treatment
Use of topical steroids, tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide, diclofenac, or photodynamic therapy (PDT) to the face within the previous 4 weeks
Subjects must not currently be taking isotretinoin (Accutane).
Creams/cosmeceuticals and/or home therapies to prevent or treat photodamage, uneven skin pigmentation, excessive erythema (redness), fine lines/wrinkles, skin laxity and/or pore size during the 4-week period before study treatment
Subjects with scarring in the treatment areas
Subjects with tattoos 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 a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
Skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area
History of keloid or hypertrophic scarring
Subjects with an active bacterial, viral, or fungal infection of the treatment areas or systemic infection
Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
History of lidocaine and/or tetracaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study
Subjects must not have a compromised ability for wound healing, such as:
malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma), atopic dermatitis, or immunologic abnormalities such as vitiligo.
Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
Presence of incompletely healed wound(s) in the treatment area
Subjects who are on an immunosuppressant or have an autoimmune condition
Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study

Where it is running

West Dermatology Research Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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