Skin Care Regimen for Improving Photoaging Signs on the Face

This study is looking at how well a skin care regimen, specifically CE Ferulic serum combined with laser treatment, works to improve signs of photoaging (skin damage from sun exposure) on the face. It's being compared to a vehicle serum (a cream or liquid without the active ingredients) also combined with laser treatment. You might be able to join if you are between 30 and 70 years old, have Fitzpatrick skin types I-VI, and are in good general health. The researchers will measure changes in fine lines, overall hyperpigmentation (dark spots), and skin tone evenness to see if the treatments are effective. The current status of this study is unclear, and they plan to enroll 40 participants.

Study design: This is an interventional study comparing two different skin care regimens combined with laser treatment. It plans to enroll 40 participants.
What's involved: You would use the assigned serum once daily for 14 weeks, including a 2-week pre-treatment period and a 12-week treatment period, along with two laser treatments. You would have examinations of your face and digital images taken at Screening, Baseline, Day 28, Day 56, and Day 84.
Compensation: Not stated in the trial record.
Follow-up: Your skin will be evaluated at Day 28, Day 56, and Day 84 after starting the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Skin Care Regimen for Improving Photoaging Signs on the Face

Not Yet Recruiting

PHASE2Ages 30–70InterventionalSupportive care

Goldman, Butterwick, Fitzpatrick and Groff

~40 participants

Updated 2024-09-19 on ClinicalTrials.gov

What's tested:CE FerulicSham Comparator1927nm (Clear and Brilliant Perméa®)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Global Fine Lines

Measured over Screening, Baseline, Day 28, Day 56, Day 84

+7 more outcomes measured

Conditions

Improve Photoaging Signs

NCT06603857

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

West Dermatology Research Center
San Diego, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

West Dermatology Research Center

[email protected]

858-657-1004

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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:

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

What this trial measures

Global Fine LinesScreening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= No fine lines present; skin looks completely smooth Score 9= Numerous, many fine lines densely packed together in the treatment area
Overall Hyperpigmentation/ DiscolorationScreening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= No hyperpigmentation Score 9= Significant hyperpigmentation, numerous spots, uneven skin tone
Skin Tone EvennessScreening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Very even tone Score 9= Uneven, discolored appearance (brown and/or red colors)
Skin ElasticityScreening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Skin feels toned, dense Score 9= Skin feels pliable, thin and non-resilient
Skin FirmnessScreening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Firm, tight feeling skin Score 9= Loose, lax feeling skin
Skin Radiance/ BrightnessScreening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Very radiant, luminous or glowing appearance Score 9= Very dull/ matte and/or sallow skin appearance
Skin Texture SmoothnessScreening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Very smooth, even-looking skin texture, no roughness Score 9= Very rough, pronounced, extensive visible skin roughness
Global WrinklesScreening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= No wrinkles present, no visible deep, wide and long wrinkles, skin looks smooth Score 9= Numerous wrinkles, deep, wide and long, densely packed together in the treatment area

Trialytics