Combination Versus Laser Treatment Only

Not Applicable

Completed

• Conditions: Photoaging
• Interventions: Device: Laser Therapy; Other: Basic Skin Care Regimen; Other: Lytera

• Registration Number: NCT03661697
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-10-10
• Primary Completion: 2019-03-07
• Study Completion: 2019-03-07
• Results First Submitted: 2020-02-18
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-23
• Results First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser only arm	Laser Therapy	4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments.
Lytera Arm	Lytera	4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments.
Lytera Arm	Laser Therapy	4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments.
Lytera Arm	Basic Skin Care Regimen	4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments.
Laser only arm	Basic Skin Care Regimen	4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments.

Primary Outcome Measures

Name	Time	Method
Change in Aesthetics	baseline to 12 weeks	Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)
Change in Skin Tone	baseline to 12 weeks	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States