Combination Versus Laser Treatment Only

April 23, 2020 updated by: Lisa Grunebaum, University of Miami

Effect of Combination Laser Treatment and Skin Brightening Topical on the Appearance of Skin Tone and Photoaging: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lytera Arm
4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments.
Device: 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.

Other Names:
  • Clear and Brilliant Permea (1927nm fractional)
Other: Basic Skin Care Regimen
Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks
Other: Lytera
cosmeceutical serum applied to face daily for 12 weeks
ACTIVE_COMPARATOR: Laser only arm
4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments.
Device: 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.

Other Names:
  • Clear and Brilliant Permea (1927nm fractional)
Other: Basic Skin Care Regimen
Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Allergan Sales, LLC

Investigators

  • Principal Investigator: Lisa Grunebaum, MD, Univeristy of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2018

Primary Completion (ACTUAL)

March 7, 2019

Study Completion (ACTUAL)

March 7, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (ACTUAL)

September 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20171006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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