Clinical trial NCT06603857: Skin Care Regimen for Improving Photoaging Signs on the Face
Official title: A Prospective, Placebo-controlled, Double-blinded, Randomized Clinical Trial Evaluating the Efficacy and Tolerability of Pre and Post Care Skincare Regimen Paired With 1927nm Diode Fractional Laser for Photodamage on the Face
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Improve Photoaging Signs
Keywords: wrinkles
aging
photodamage
Lead sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Sponsor class: OTHER
Collaborators: name: L'Oreal
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, placebo-controlled, double-blinded, randomized study
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Evaluate the efficacy and tolerability of a Skinceuticals CE Ferulic® when used once daily over the course of 14 weeks with 2-week pre-treatment period and 12-week treatment period in pairing with two pre-elected laser treatments with 1927nm non-ablative fractional diode laser treatment for improving skin photoaging signs on the face.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Global Fine Lines
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Overall Hyperpigmentation/ Discoloration
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Skin Tone Evenness
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Skin Elasticity
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Skin Firmness
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Skin Radiance/ Brightness
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Skin Texture Smoothness
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Global Wrinkles
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
Secondary outcomes:
measure: Tolerability Assessment
timeFrame: Baseline, Day 28
measure: Dermatology Quality of Life Index (Page 1)
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Dermatology Quality of Life Index (Page 2)
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Subject Self-Assessment Questionnaire (Page 1)
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Subject Self-Assessment Questionnaire (Page 2)
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
measure: Subject Self-Assessment Questionnaire (Page 3)
timeFrame: Screening, Baseline, Day 28, Day 56, Day 84
Other outcomes:
Locations:
city: San Diego
country: United States
facility: West Dermatology Research Center
state: California
Study officials:
References: