Combination Versus Laser Treatment Only

NCT03661697 | Completed Results FDA Device

• 1 other identifier: 20171006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Our objective is to determine the effects of (1) basic skin care regimen + "active" (Lytera 2.0) vs. (2) basic skin care regimen only, both groups combined with laser, on the appearance of skin tone and photo-aging on the face.

Conditions

Photoaging

Keywords

skin; sun damage; photoaging of face; skin care; laser therapy

Outcome Measures

Primary Outcomes (2)

• Change in Aesthetics

  Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)

  baseline to 12 weeks

• Change in Skin Tone

  Change in skin tone is assessed using the Modified Pigmentation Area and Severity Index (MoPASI). MoPASI assesses three facial region variables: 1) A = % area of involvement (0 = no involvement, 6 = 90% involvement), 2) D = darkness of pigment (0=absent, 4=maximum), 3) P = pattern of involvement (0=absent, 4=maximum). Four facial regions will be assessed: Forehead (0.2A), Left Cheek and periorbital (0.3A), Right Cheek and periorbital (0.3A), Nose/Lip/Chin (0.2A). The Total score ranges from 0-48 and is calculated using the formula: MoPASI = 0.2A(D + P) + 0.3A (D+P) + 0.3A (D+P) + 0.2A (D+P). A higher score indicates higher pigmentation.

  baseline to 12 weeks

Study Arms (2)

Lytera Arm

EXPERIMENTAL

4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments.

Device: Laser Therapy; Other: Basic Skin Care Regimen; Other: Lytera

Laser only arm

ACTIVE COMPARATOR

4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments.

Device: Laser Therapy; Other: Basic Skin Care Regimen

Interventions

Laser Therapy DEVICE

Clear and Brilliant Permea is a 1927nm fractional laser with 3 settings; low, medium, high. All interventions were done at low with four passes to each participant's full face.

Also known as: Clear and Brilliant Permea (1927nm fractional)

Laser only arm; Lytera Arm

Basic Skin Care Regimen OTHER

Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks

Laser only arm; Lytera Arm

Lytera OTHER

cosmeceutical serum applied to face daily for 12 weeks

Lytera Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult male and female patients 18 years and older
• Fitzpatrick skin types I-IV
• Has at least mild mottled skin tone of the face (score of 2 or more on a 5 point skin tone scale)
• Has at least 2 areas of the face with significant roughness, dyspigmentation, or fine lines or has all these characteristics in 1 or more areas
• Willing to refrain from using any other topical products on the face, systemic retinoids, or steroids, facial peels or other facial laser procedures throughout the duration of the study
• Willing to refrain from any cosmetic procedure including but not limited to facial surgery, dermal fillers, and neuromodulators for the duration of the study
• Willing to use only the facial skin care product regimen provided for the study
• Willing to avoid extended periods of sun exposure and the use of tanning beds during the study
• Willing to have photographs taken of the face to be used de-identified in evaluations, publications, and presentations
• For females: proof that they are not pregnant (urine pregnancy test)
• English-speaker

You may not qualify if:

• Has any uncontrolled systemic disease (such as autoimmune disorders and connective tissue disorders such as lupus erythematosus or Sjogren's syndrome
• Has any active infection in face
• Has history of any skin conditions that could interfere with treatment
• Has used self-tanner recently
• Is currently participating in another drug research study
• Is NOT willing to refrain from using any other topical products such as skin lightening, retinoids, alpha/beta-hydroxyl acids, salicylic acid, vitamins C or D, steroids, or antibiotics on the face or systemic retinoids, steroids, facial peels, neuromodulators, dermal fillers, facial surgery, or other facial laser procedures throughout the duration of the study
• For females: is pregnant
• Non English-speaker

Sponsors & Collaborators

• University of Miami: lead
• Allergan Sales, LLC: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Lisa D Grunebaum MD
• Organization: University of Miami

lgrunebaum@med.miami.edu

3052433223

Study Officials

• Lisa Grunebaum, MD

  Univeristy of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Facial Plastic and Reconstructive Surgery and Dermatology

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: October 10, 2018
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)