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OpenTrials
Completed

NCT Number: NCT03661697

Combination Versus Laser Treatment Only

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser Therapy

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.

Other names: Clear and Brilliant Permea (1927nm fractional)

Basic Skin Care Regimen

Other

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

Lytera

Other

cosmeceutical serum applied to face daily for 12 weeks

Primary outcomes

  1. Change in Aesthetics

    Time frame: baseline to 12 weeks

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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Allergan Sales, LLC

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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