Combination Versus Laser Treatment Only

NCT ID: NCT03661697

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2019-03-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lytera Arm

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

Group Type: EXPERIMENTAL

Laser Therapy

Intervention Type: 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.

Basic Skin Care Regimen

Intervention Type: OTHER

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

Lytera

Intervention Type: OTHER

cosmeceutical serum applied to face daily for 12 weeks

Laser only arm

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

Group Type: ACTIVE_COMPARATOR

Laser Therapy

Intervention Type: 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.

Basic Skin Care Regimen

Intervention Type: OTHER

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

Interventions

Laser Therapy

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.

Intervention Type: DEVICE

Basic Skin Care Regimen

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

Intervention Type: OTHER

Lytera

cosmeceutical serum applied to face daily for 12 weeks

Intervention Type: OTHER

Other Intervention Names

Clear and Brilliant Permea (1927nm fractional)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan Sales, LLC

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Lisa Grunebaum

Associate Professor of Facial Plastic and Reconstructive Surgery and Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Grunebaum, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20171006

Identifier Type: -

Identifier Source: org_study_id