Laser Treatment + CE Ferulic for Wrinkles

Overseen By West Dermatology Research Center

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Must not be taking: Isotretinoin, Topical steroids

Disqualifiers: Skin conditions, Infections, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Adults aged 30-70 with mild to moderate facial wrinkles, willing to undergo laser treatment and use birth control if applicable. Excludes those with certain skin conditions, allergies, or recent cosmetic procedures.

Inclusion Criteria

Fitzpatrick skin types I-VI

Physician evaluator classifying the subject as mild to moderate (Score 3-6) on the modified Griffiths 10-Point Scale for the face

Must be willing to give and sign an informed consent form and photographic release form

Exclusion Criteria

History of keloid or hypertrophic scarring

Any investigational treatment for improvement of skin quality and/or photodamage of facial skin during the 6-month period before the study treatment

Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Pre-treatment

Participants use Skinceuticals CE Ferulic® or vehicle serum once daily for 2 weeks before laser treatment

2 weeks

1 visit (in-person)

Treatment

Participants receive two treatments with 1927nm non-ablative fractional diode laser paired with either Skinceuticals CE Ferulic® or vehicle serum

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• CE Ferulic

Trial Overview The trial tests the effectiveness of a laser treatment combined with CE Ferulic serum versus a sham comparator for improving signs of aging on the face.

Participant Groups

Group I: Group A Active Control 2 Interventions

Subjects who will receive two treatments with 1927nm (Clear and Brilliant Perméa®) non-ablative fractional diode laser for rejuvenation of photodamaged skin of the face in pairing with Skinceuticals CE Ferulic

Group II: Group B Placebo Group 2 Interventions

Subjects who will receive two treatments with 1927nm (Clear and Brilliant Perméa®) non-ablative fractional diode laser for rejuvenation of photodamaged skin of the face in pairing with vehicle serum

Who Is Running the Clinical Trial?

Goldman, Butterwick, Fitzpatrick and Groff

Lead Sponsor

Trials

32

Recruited

660+

L'Oreal

Industry Sponsor

Trials

22

Recruited

11,100+