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Trial Evaluating Both Tolerability and Improvement for Signs of Facial Photoaging, Discoloration, and Texture in Adult Females of All Skin Types by Combining a Placebo Moisturizer and Non-ablative Laser.

NCT06090071 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-10-24

No results posted yet for this study

Summary

This is a phase 4 trial evaluating the clinical effect of combining a placebo moisturizer and non-ablative laser to improve procedural outcomes in patients with facial dyschromia. This study's objective is to evaluate both the tolerability and improvement in signs of photoaging for a placebo moisturizer used in combination with a non-ablative laser. Physician assessments, patient reported outcomes, and digital photos will be captured.

Conditions

  • Photoaging

Interventions

DEVICE

LaseMD Laser

The non-ablative fractional 1,927nm Thulium laser will be used in this study. This FDA-approved laser is an innovative device addressing as well as medical as aesthetic and cosmetic indications. The system allows nearly pain free treatments with depth of 200 μm setting multiple microbeams. The stratum corneum stays intact despite superficial ruptures, coagulation zones appear only in the underlying layers of the skin.

DEVICE

Sciton Laser

The Sciton Laser uses Broadband light (BBL), also known as intense pulse light, a commonly available and popular treatment to rejuvenate the skin. BBL uses a broad band of noncoherent light waves, ranging from 560 to 1,200 nm, that are absorbed by a number of components in the skin, leading to a reduction in dyschromia, background erythema, telangiectasia, and an increase in collagen production resulting in amelioration of fine lines.

DRUG

Phyto A+ Brightening Treatment

Phyto A+ Brightening Treatment is a serum comprised of a soothing botanical blend matched with a keratolytic (3% azeleic acid), 2.5% niacinamide, a brightening compound (2 % α-arbutin), and botanical extracts

Sponsors & Collaborators

  • SkinCeuticals

    collaborator UNKNOWN

  • Austin Institute for Clinical Research

    lead NETWORK

Principal Investigators

  • Edward Lain, MD, MBA · Austin Institute for Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2024-09-05
Completion
2024-09-05
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06090071 on ClinicalTrials.gov