Skin Care Regimen for Improving Photoaging Signs on the Face

NCT06603857 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: Skinceuticals CE Ferulic 2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Improve Photoaging Signs

Keywords

wrinkles; aging; photodamage

Outcome Measures

Primary Outcomes (8)

• Global Fine Lines

  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

  Screening, Baseline, Day 28, Day 56, Day 84

• Overall Hyperpigmentation/ Discoloration

  Score 0 thru 9 Score 0= No hyperpigmentation Score 9= Significant hyperpigmentation, numerous spots, uneven skin tone

  Screening, Baseline, Day 28, Day 56, Day 84

• Skin Tone Evenness

  Score 0 thru 9 Score 0= Very even tone Score 9= Uneven, discolored appearance (brown and/or red colors)

  Screening, Baseline, Day 28, Day 56, Day 84

• Skin Elasticity

  Score 0 thru 9 Score 0= Skin feels toned, dense Score 9= Skin feels pliable, thin and non-resilient

  Screening, Baseline, Day 28, Day 56, Day 84

• Skin Firmness

  Score 0 thru 9 Score 0= Firm, tight feeling skin Score 9= Loose, lax feeling skin

  Screening, Baseline, Day 28, Day 56, Day 84

• Skin Radiance/ Brightness

  Score 0 thru 9 Score 0= Very radiant, luminous or glowing appearance Score 9= Very dull/ matte and/or sallow skin appearance

  Screening, Baseline, Day 28, Day 56, Day 84

• Skin Texture Smoothness

  Score 0 thru 9 Score 0= Very smooth, even-looking skin texture, no roughness Score 9= Very rough, pronounced, extensive visible skin roughness

  Screening, Baseline, Day 28, Day 56, Day 84

• Global Wrinkles

  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

  Screening, Baseline, Day 28, Day 56, Day 84

Secondary Outcomes (6)

• Tolerability Assessment

  Baseline, Day 28

• Dermatology Quality of Life Index (Page 1)

  Screening, Baseline, Day 28, Day 56, Day 84

• Dermatology Quality of Life Index (Page 2)

  Screening, Baseline, Day 28, Day 56, Day 84

• Subject Self-Assessment Questionnaire (Page 1)

  Screening, Baseline, Day 28, Day 56, Day 84

• Subject Self-Assessment Questionnaire (Page 2)

  Screening, Baseline, Day 28, Day 56, Day 84

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: CE Ferulic; Device: 1927nm (Clear and Brilliant Perméa®)

Group B

SHAM COMPARATOR

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

Drug: Sham Comparator; Device: 1927nm (Clear and Brilliant Perméa®)

Interventions

CE Ferulic DRUG

CE Ferulic serum regimen combined with laser treatment

Group A

Sham Comparator DRUG

Vehicle serum regimen combined with laser treatment

Group B

1927nm (Clear and Brilliant Perméa®) DEVICE

non-ablative fractional diode laser

Group A; Group B

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• L'Oreal: collaborator

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

Central Study Contacts

West Dermatology Research Center

CONTACT

858-657-1004; research@clderm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The blinded investigator will perform assessments at all study visits.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, placebo-controlled, double-blinded, randomized study

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 27, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)