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Combination Versus Laser Treatment Only

Primary Purpose

Photoaging

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Therapy
Basic Skin Care Regimen
Lytera
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photoaging focused on measuring skin, sun damage, photoaging of face, skin care, laser therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lytera Arm

Laser only arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 5, 2018
Last Updated
April 23, 2020
Sponsor
University of Miami
Collaborators
Allergan Sales, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03661697
Brief Title
Combination Versus Laser Treatment Only
Official Title
Effect of Combination Laser Treatment and Skin Brightening Topical on the Appearance of Skin Tone and Photoaging: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Allergan Sales, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoaging
Keywords
skin, sun damage, photoaging of face, skin care, laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lytera Arm
Arm Type
Experimental
Arm Description
4 week washout period with skin care regimen including Lytera 2.0 followed by 2 laser treatments.
Arm Title
Laser only arm
Arm Type
Active Comparator
Arm Description
4 week washout period with a basic skin care regimen, no Lytera 2.0, followed by 2 laser treatments.
Intervention Type
Device
Intervention Name(s)
Laser Therapy
Other Intervention Name(s)
Clear and Brilliant Permea (1927nm fractional)
Intervention Description
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
Other
Intervention Name(s)
Basic Skin Care Regimen
Intervention Description
Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks
Intervention Type
Other
Intervention Name(s)
Lytera
Intervention Description
cosmeceutical serum applied to face daily for 12 weeks
Primary Outcome Measure Information:
Title
Change in Aesthetics
Description
Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)
Time Frame
baseline to 12 weeks
Title
Change in Skin Tone
Description
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.
Time Frame
baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Grunebaum, MD
Organizational Affiliation
Univeristy of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Combination Versus Laser Treatment Only

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