Clinical trial NCT03661697: 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
Overall status: COMPLETED
Phase: NA
Conditions: Photoaging
Keywords: skin
sun damage
photoaging of face
skin care
laser therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Allergan Sales, LLC
First posted: 2018-09-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Aesthetics
timeFrame: baseline to 12 weeks
measure: Change in Skin Tone
timeFrame: baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: Univeristy of Miami
name: Lisa Grunebaum, MD
role: PRINCIPAL_INVESTIGATOR
References: