Combination Versus Laser Treatment Only

University of Miami

Status: Completed

Conditions: Photoaging

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03661697

20171006

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Lytera Arm

Experimental group

Description:

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

Treatment:

Device: Laser Therapy

Other: Lytera

Other: Basic Skin Care Regimen

Laser only arm

Active Comparator group

Description:

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

Treatment:

Device: Laser Therapy

Other: Basic Skin Care Regimen