N/A
N=14
Combination Versus Laser Treatment Only
Photoaging
Bottom Line
View on ClinicalTrials.gov: NCT03661697 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change in Aesthetics — 2; 1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laser Therapy (Device); Basic Skin Care Regimen (Other); Lytera (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Aesthetics |
2; 1 | — |
| PRIMARY Change in Skin Tone |
-8.7; -3.90 | — |
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
Data sourced from ClinicalTrials.gov (NCT03661697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.