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 | Completed Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: PDCR-000297
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

facial dyschromia

Outcome Measures

Primary Outcomes (1)

• Change in facial dyschromia

  Measured by Live Clinical Investigator Assessment including, Skin Clarity, Appearance of Pores, Skin Texture/Smoothness (Visual), Skin Texture/Smoothness (Tactile), Hyperpigmentation, Skin Tone Evenness, Radiance/Brightness and Overall Healthy Appearance of Skin/Overall Skin Quality, and Tolerance Evaluation. Local cutaneous tolerability will be evaluated by assessing the signs of erythema, dryness, and scaling and by subject reporting of the degree of burning, stinging, and itching. Local cutaneous tolerability will all be measured with the parameters of 0 = none, 1 = mild, 2 = moderate, 3 = severe.

  Change from Baseline to Day 98

Study Arms (2)

Phyto A+ Brightening Treatment

ACTIVE COMPARATOR

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. Product will be topically applied to the assigned side of the face, either left or right side, at Day 0, Day 14, Day 28, Day 42, Day 70, and Day 98.

Device: LaseMD Laser; Device: Sciton Laser; Drug: Phyto A+ Brightening Treatment

Placebo Moisturizer

PLACEBO COMPARATOR

Placebo Moisturizer will be topically applied to the assigned side of the face, either left or right side, at Day 0, Day 14, Day 28, Day 42, Day 70, and Day 98.

Device: LaseMD Laser; Device: Sciton Laser; Drug: Phyto A+ Brightening Treatment

Interventions

LaseMD Laser DEVICE

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.

Phyto A+ Brightening Treatment; Placebo Moisturizer

Sciton Laser DEVICE

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.

Phyto A+ Brightening Treatment; Placebo Moisturizer

Phyto A+ Brightening Treatment DRUG

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

Phyto A+ Brightening Treatment; Placebo Moisturizer

Eligibility Criteria

• Age: 25 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female subjects aged between 25 and 70 years, all skin types included
• Symmetrical photoaging
• No known medical conditions that, in the Investigator's opinion may interfere with study participation
• Willingness to cooperate and participate by following study requirements
• Female subjects of childbearing potential must be willing to use appropriate contraception method(s)
• Individuals must sign an informed consent and a photography consent

You may not qualify if:

• Subjects that are being treated for cancer or have a history of facial skin cancer on the test areas
• Subjects with sunburn, moderate to pronounced suntan, pronounced asymmetric skin aging, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might include the test results
• Subjects currently taking certain medications which in the opinion of the Investigator(s) may interfere with the study. This includes but is not limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids \[steroid nose drops, inhalers and/or eye drops are permitted\]), and immunosuppessive drugs
• Subjects with self-reported, uncontrolled systemic disease which, in the opinion of the Investigator, may hinder either the subject's ability to perform all responsibilities of the trial or the Investigator's ability to perform assessments
• Women known to be pregnant, nursing or planning to become pregnant
• Subjects participating in other facial clinical studies
• Subjects who have routinely used an alpha-hydroxy-acid (AHA) or a beta-hydroxy-acid (BHA) containing product within two weeks or Retin-A, Retin-A Micro, Renova, Differin, Avita, Tazorac, or Soriatane within 8 weeks of the study start or have taken Isotretinoin within one year of the study start.
• Subjects who have used Retinol in the last 4 weeks
• Subjects with current flaring severe inflammatory acne
• Subjects who have had ablative laser treatments, microneedling, and/or chemical peels or dermabrasion within the last six months
• Subjects who have had botulinum type-A toxin (e.g. Botox®, Daxxify®, Dysport®, Jeaveau®, or Xeomin®) within the last 6 months
• Subjects who have had dermal filler injections within the last 12 months
• Subjects who have had non-ablative laser treatments or IPL within the last 3 months
• Subjects with known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
• Subjects currently using topically applied prescription medications on the face

Sponsors & Collaborators

• Austin Institute for Clinical Research: lead
• SkinCeuticals: collaborator

Study Sites (1)

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Study Officials

• Edward Lain, MD, MBA

  Austin Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phyto A+ Brightening Treatment and placebo moisturizer will be labeled as Study Product A or Study Product B. Subjects, delegated site staff, or investigators will not know which product is applied to either side of the face.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Split-Face study design. Phyto A+ Brightening Treatment and placebo moisturizer will be randomized regardless of Fitzpatrick Skin Type (FST). Subjects will be assigned to a laser treatment based on their Fitzpatrick Skin Type, as determined by the Investigator. Subjects with FST I-III will receive the Sciton laser procedure. Subjects with FST IV-VI will receive LaseMD laser procedure. Half of the face will be treated with Phyto A+ Brightening Treatment and assigned laser treatment. The other half of the face will be treated with placebo moisturizer and assigned laser treatment.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: November 14, 2023
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

US (1)