Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea

NCT04153188 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: DHF24671
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

This study will compare treatment outcome with pulsed dye laser, when used used as an adjunctive treatment to oxymetazoline HCl 1% cream, compared to oxymetazoline HCL 1% cream alone, for patients with moderate or severe erythematotelangiectatic rosacea.

Conditions

Erythematotelangiectatic Rosacea

Keywords

Erythema; Rosacea; Telangiectasia; pulsed dye laser; oxymetazoline hydrochloride 1% cream

Outcome Measures

Primary Outcomes (1)

• Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline

  CEA was graded by the investigator according to 5-point scale (0=Clear to 4=Severe) for each patient at the 6-month post-baseline visits. A higher score indicates worse outcome. The outcomes presented here are the mean CEA calculated for the 6-month post-baseline visit of each arm.

  6-month post-baseline

Secondary Outcomes (7)

• Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits

  1- ,2- and 3-Month Post-Baseline Visits

• Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits

  1-, 2-, 3- and 6-months post-baseline

• Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline

  1-, 2-, 3- and 6-month post-baseline

• Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline

  1-, 2-, 3- and 6-month post-baseline

• Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits

  1-, 2-, 3- and 6-month post-baseline

Study Arms (2)

Pulsed Dye Laser & Oxymetazoline HCL 1% Cream

EXPERIMENTAL

Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments.

Device: The Vbeam® Prima System; Drug: Oxymetazoline HCL 1% Cream

Oxymetazoline HCL 1% Cream

ACTIVE COMPARATOR

Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study.

Drug: Oxymetazoline HCL 1% Cream

Interventions

The Vbeam® Prima System DEVICE

3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.

Also known as: Vbeam® Prima Pulsed Dye Laser Treatment, Pulsed Dye Laser Treatment, PDL Treatment

Pulsed Dye Laser & Oxymetazoline HCL 1% Cream

Oxymetazoline HCL 1% Cream DRUG

Daily application of Oxymetazoline HCL 1% cream for the 6-month study.

Also known as: RHOFADE®

Oxymetazoline HCL 1% Cream; Pulsed Dye Laser & Oxymetazoline HCL 1% Cream

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a healthy male or female of 18 to 75 years of age.
• Subject has erythematotelangiectatic rosacea with clinician erythema assessment (CEA) and subject self-assessment (SSA) of "moderate" or "severe" (Grade 3 or 4).
• Fitzpatrick Skin Type I - VI.
• Subject must be able to read, understand and sign the Informed Consent Form.
• Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
• Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period up to 6 months post-baseline.
• Subject is willing to have photographs taken of the treated area that will be used, de-identified, in evaluations and may be used, de-identified, in presentations and/or publications.
• For female candidates - subject must be post-menopausal, or surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.

You may not qualify if:

• Subject is pregnant or planning to become pregnant during the study duration.
• Subject has an active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• Subject has an implant in the treated area (such as metal plates or screws) or an injected chemical substance.
• Subject has a known collagen (connective tissue) disorder, vascular disease, scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
• Subject has a history of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
• Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• Having or undergoing any form of treatment for active cancer or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
• Subject is suffering from significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
• Subject has an infection or is suffering from current or has a history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: photodermatoses, active acne, excessive skin dryness, psoriasis, eczema, rash, open wounds, varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
• Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
• Subject has a history of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• Subject has a history of keloid scarring or of abnormal wound healing.
• Subject has a known photosensitivity to the device's laser wavelengths, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
• Subject has undergone any surgical, light-based therapy or radiofrequency (RF) procedures in the treatment area within 3 months of treatment or during the study.
• Having undergone any other surgery in the treated area within 3 months of treatment (or more if skin has not healed completely) or during the study.

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (2)

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Dermatology & Laser Surgery Center

Houston, Texas, 77030, United States

Location

Related Publications (5)

• Tan J, Liu H, Leyden JJ, Leoni MJ. Reliability of Clinician Erythema Assessment grading scale. J Am Acad Dermatol. 2014 Oct;71(4):760-3. doi: 10.1016/j.jaad.2014.05.044. Epub 2014 Jul 4.

  PMID: 24999270 BACKGROUND

• DuBois J, Dover JS, Jones TM, Weiss RA, Berk DR, Ahluwalia G. Phase 2 Randomized, Dose-Ranging Study of Oxymetazoline Cream for Treatment of Persistent Facial Erythema Associated With Rosacea. J Drugs Dermatol. 2018 Mar 1;17(3):308-316.

  PMID: 29537449 BACKGROUND

• Bernstein EF, Schomacker K, Paranjape A, Jones CJ. Pulsed dye laser treatment of rosacea using a novel 15 mm diameter treatment beam. Lasers Surg Med. 2018 Oct;50(8):808-812. doi: 10.1002/lsm.22819. Epub 2018 Apr 10.

  PMID: 29635699 BACKGROUND

• Suggs AK, Macri A, Richmond H, Munavalli G, Friedman PM. Treatment of Erythematotelangiectatic Rosacea With Pulsed-Dye Laser and Oxymetazoline 1.0% Cream: A Retrospective Study. Lasers Surg Med. 2020 Jan;52(1):38-43. doi: 10.1002/lsm.23176. Epub 2019 Nov 10.

  PMID: 31709571 BACKGROUND

• Sodha P, Suggs A, Munavalli GS, Friedman PM. A Randomized Controlled Pilot Study: Combined 595-nm Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride Topical Cream Superior to Oxymetazoline Hydrochloride Cream for Erythematotelangiectatic Rosacea. Lasers Surg Med. 2021 Dec;53(10):1307-1315. doi: 10.1002/lsm.23439. Epub 2021 Jul 7.

  PMID: 34233378 RESULT

MeSH Terms

Conditions

Rosacea; Erythema; Telangiectasis

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Small sample size for randomization

Results Point of Contact

• Title: Medical Director
• Organization: Candela Corporation

konikap@candelamedical.com

+1 904 6549629

Study Officials

• Konika P Schallen, MD

  Candela Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects randomized at baseline to either 3 monthly treatments with PDL and daily oxymetazoline 1.0% cream (Arm 1) or oxymetazoline cream alone (Arm 2).

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: January 15, 2019
• Primary Completion: November 13, 2020
• Study Completion: January 5, 2021
• Last Updated: March 31, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)