Evaluating the Efficacy and Safety of Cleanser, Serum, and Sunscreen Products for Facial Redness.

A Prospective, Open Label Clinical Study Evaluating the Efficacy and Safety of Cleanser, Serum, and Sunscreen Products for the Treatment of Facial Redness.

The primary objective of this study is to assess the efficacy and safety of combination therapy of a Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen in the treatment of redness.

Study Overview

• Status: Not yet recruiting
• Conditions: Redness
• Intervention / Treatment: Drug: Barrier Renew

Detailed Description

Enrolled subjects will undergo treatment with Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen. Cleanser and Barrier Renew PM moisturizer will be used twice daily. Mineral sunscreen will be used every morning and throughout the day as indicated.

Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory photography using the VISIA system will be done. Patients will return for follow-up assessments at week 2, 4 and 8.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Andrea Pacheco; Phone Number: 858-657-1004; Email: apacheco@clderm.com
• Study Contact Backup: Name: Freia Canals Cistero, RN; Phone Number: 8586571004; Email: freia.canals@westderm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women between the ages of 18 and 60 years old (inclusive)
• Subjects must be able and willing to provide written informed consent and photography release

• At the baseline evaluation, all subjects must exhibit all of the following:

  1. Mild to moderate confluent facial redness or blotchy redness
  2. Mild to moderate score (1-6) for tactile roughness or dryness.
• Subject must be in good general health with no other skin disease, disease state or physical condition which would impair evaluation of the areas to be treated or which would increase the subject's health risk by study participation.
• Subjects must have a willingness to minimize sun exposure, avoid direct sun exposure on the face, and avoid the use of tanning beds for the entire duration of the study. Must be willing to wear a hat and reapply sunscreen if sun exposure is unavoidable.
• Subjects must be willing and able to understand and comply with the requirements of the study including minimizing external factors that might trigger redness flare-ups (e.g. spicy foods, excessively hot or cold environments, prolonged sun exposure, strong winds and alcoholic beverages), apply the products as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.

• For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.

  1. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
  2. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.

Exclusion Criteria:

• Subjects who are pregnant, planning a pregnancy, or nursing a child.
• Subject using systemic or topical anti-inflammatory agents with the exception of OTC acetaminophen (e.g., Tylenol), ibuprofen (e.g., Advil), or aspirin for 5 days prior to the baseline visit and the duration of the trial
• Subject who could not agree to not use systemic or topical anti-inflammatory agents, with the exception of OTC acetaminophen (e.g., Tylenol), ibuprofen (e.g., Advil), or aspirin during the course of the study.
• Subjects who exhibit severe or advanced redness (persistent deep erythema, telangiectasia forming sprays, papules, pustules, nodules with variable plaque-like edema, or phymatous change).

• Subjects who have used a personal product on the face prior to the study start, which in the opinion of the investigator could interfere with the evaluation of the test articles in the time frame below

  1. Retinoids and other vitamin A derivatives within 1 month
  2. Exfoliating and/or keratolytic products including alpha- or beta-hydroxy acids within 2 weeks

• Subjects who have taken a medication prior to the study start, which in the opinion of the investigator could interfere with the evaluation of the test articles. These medications may include, but are not limited to, the use of any medication to treat rosacea, oral or topical antibiotics, steroids, antifungals, antimicrobials or acne medications for two weeks prior to study start or the time period specified below

  1. Systemic retinoids within 6 months
  2. Systemic tetracycline class antibiotics within 2 months
  3. Systemic macrolide antibiotics within 4 weeks
  4. Initiation of change in hormonal therapy within 3 months
• Subjects with a recent history of atopic dermatitis/eczema or contact dermatitis
• Subjects who are currently under treatment for asthma or diabetes.
• Subjects with any medical condition of the face that could interfere with the study
• Subjects with facial piercings or tattoos that in the Investigator's opinion may hide the diagnosis or disrupt the treatment. Subject agrees not get any facial piercings or tattoos during the study.
• Subjects who are not willing to remove jewelry (earrings), make up and false eyelashes/lash extensions prior to photography.
• Ocular involvement, such as conjunctivitis, episcleritis, iritis, or keratitis.
• History of hypersensitivity or allergy to any of the product ingredients.
• Laser, chemical peel, or surgery on the facial area within 3 months prior to baseline.
• Recent history (<1 year) of substance use disorder
• Subjects that have participated in a clinical research trial in the past 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen.; Enrolled subjects will all receive Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen. Cleanser and Barrier Renew PM moisturizer will be used twice daily. Mineral sunscreen will be used every morning and throughout the day as indicated.	Drug: Barrier Renew; RoC Skincare (New York, New York, USA) has developed a gentle cleanser and moisturizer that are free of exfoliants, astringents, and other abrasive ingredients. The moisturizer contains emollients, humectants, and silicones to improve the functioning of the skin barrier while antioxidants protect against environmental damage and inflammation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Evaluator assessment of change of improvement using the expert grading scale for Dryness/Scaling/Roughness	Use the following to answer below: None= 0 None No erythema or redness of the treatment area Mild= 1-3 Mild Slight, but definite redness of the treatment area Moderate= 4-6 Moderate Definite redness of the treatment area Severe= 7-9 Severe Marked redness of the treatment area Using the grading scale above please circle the best answer Dryness/Scaling/Roughness= None Mild Moderate Severe	Baseline, Day 14, Day 30, Day 60
Clinician Evaluator assessment of change of improvement using the expert grading scale for Luminosity	Use the following to answer below: None= 0 None No erythema or redness of the treatment area Mild= 1-3 Mild Slight, but definite redness of the treatment area Moderate= 4-6 Moderate Definite redness of the treatment area Severe= 7-9 Severe Marked redness of the treatment area Using the grading scale above please circle the best answer Luminosity= None Mild Moderate Severe	Baseline, Day 14, Day 30, Day 60
Clinician Evaluator assessment of change of improvement using the expert grading scale for Redness	Use the following to answer below: None= 0 None No erythema or redness of the treatment area Mild= 1-3 Mild Slight, but definite redness of the treatment area Moderate= 4-6 Moderate Definite redness of the treatment area Severe= 7-9 Severe Marked redness of the treatment area Using the grading scale above please circle the best answer Redness/Erythema= None Mild Moderate Severe	Baseline, Day 14, Day 30, Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Self Assessment Questionnaire	Agree strongly Agree Neither agree nor disagree Disagree Disagree Strongly; Cleanser/moisturizer helped reduce the redness of my facial skin.; Cleanser/moisturizer calmed and soothed my dry, irritated skin.; Cleanser/moisturizer helped reduce the dryness/tightness of my skin.; Cleanser/moisturizer helped reduce the unevenness of my skin.; Cleanser/moisturizer left my skin radiant/brighter.; Cleanser/moisturizer leaves my skin softer.; Cleanser/moisturizer leaves my skin smoother.; Cleanser/moisturizer soothes my skin.; Cleanser/moisturizer is gentle.; Cleanser/moisturizer makes my skin feel and look less sensitive.; Cleanser/moisturizer regimen leaves skin healthy looking.; Cleanser/moisturizer regimen helped reduce the flakiness of my skin.; Cleanser/moisturizer regimen helped skin to be less reactive.; This simplifies my sensitive skin/rosacea routine.	Day 14, Day 30, Day 60
Clinician Evaluator assessment of change in tolerability Stinging/Burning	Stinging/Burning None (Score of 0) No stinging/burning of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite stinging/burning of the treatment area Moderate (Score of 4, 5 or 6) Definite stinging/burning of the treatment area Severe (Score of 7, 8 or 9) Marked stinging/burning of the treatment area	Baseline, Day 14, Day 30, Day 60
Clinician Evaluator assessment of change in tolerability Itching	Itching None (Score of 0) No itching of the treatment area. Mild (Score of 1, 2 or 3) Slight, but definite itching of the treatment area. Moderate (Score of 4, 5 or 6) Definite itching of the treatment area that is distracting from daily activities. Severe (Score of 7, 8 or 9) Marked itching of the treatment area that wakes you up at night.	Baseline, Day 14, Day 30, Day 60
Clinician Evaluator assessment of change in tolerability Tightness	Tightness: None (Score of 0) No tightness of the treatment area. Mild (Score of 1, 2 or 3) Slight, but definite tightness of the treatment area. Moderate (Score of 4, 5 or 6) Definite tightness of the treatment area. Severe (Score of 7, 8 or 9) Marked tightness of the treatment area.	Baseline, Day 14, Day 30, Day 60
Clinician Evaluator assessment of change in tolerability Rash	Rash None (Score of 0) No new rash over the treatment area. Mild (Score of 1, 2 or 3) New rash covering some of the treatment area Moderate (Score of 4, 5 or 6) New rash covering much of the treatment area Severe (Score of 7, 8 or 9) New rash covering the entirety of the treatment area	Baseline, Day 14, Day 30, Day 60

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: RoC Opco LLC

Publications and helpful links

General Publications

• Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5.
• Juliandri J, Wang X, Liu Z, Zhang J, Xu Y, Yuan C. Global rosacea treatment guidelines and expert consensus points: The differences. J Cosmet Dermatol. 2019 Aug;18(4):960-965. doi: 10.1111/jocd.12903. Epub 2019 Feb 26.
• Baldwin H, Santoro F, Lachmann N, Teissedre S. A novel moisturizer with high sun protection factor improves cutaneous barrier function and the visible appearance of rosacea-prone skin. J Cosmet Dermatol. 2019 Dec;18(6):1686-1692. doi: 10.1111/jocd.12889. Epub 2019 Feb 25.

Study record dates

Study Major Dates

• Study Start (Estimated): August 11, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: red; facial redness
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: ROC-Rosacea-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No