Combination Versus Laser Treatment Only

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661697
• Other study ID #: 20171006
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: March 7, 2019

Study information

• Verified date: April 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Photoaging
• Skin Diseases

Intervention

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:
• Basic Skin Care Regimen
Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks
• Lytera
cosmeceutical serum applied to face daily for 12 weeks

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Allergan Sales, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Aesthetics	Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)	baseline to 12 weeks
Primary	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.	baseline to 12 weeks