search
Back to results

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

Primary Purpose

Redness

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Barrier Renew
Sponsored by
Goldman, Butterwick, Fitzpatrick and Groff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Redness focused on measuring facial redness, red

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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: Mild to moderate confluent facial redness or blotchy redness 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. 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. 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 Retinoids and other vitamin A derivatives within 1 month 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 Systemic retinoids within 6 months Systemic tetracycline class antibiotics within 2 months Systemic macrolide antibiotics within 4 weeks 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen.

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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

    Secondary Outcome Measures

    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.
    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
    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.
    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.
    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

    Full Information

    First Posted
    July 18, 2023
    Last Updated
    August 4, 2023
    Sponsor
    Goldman, Butterwick, Fitzpatrick and Groff
    Collaborators
    RoC Opco LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05961579
    Brief Title
    Evaluating the Efficacy and Safety of Cleanser, Serum, and Sunscreen Products for Facial Redness.
    Official Title
    A Prospective, Open Label Clinical Study Evaluating the Efficacy and Safety of Cleanser, Serum, and Sunscreen Products for the Treatment of Facial Redness.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 11, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Goldman, Butterwick, Fitzpatrick and Groff
    Collaborators
    RoC Opco LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Redness
    Keywords
    facial redness, red

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    Subjects will be treated 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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen.
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Barrier Renew
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Clinician Evaluator assessment of change of improvement using the expert grading scale for Redness
    Description
    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
    Time Frame
    Baseline, Day 14, Day 30, Day 60
    Title
    Clinician Evaluator assessment of change of improvement using the expert grading scale for Dryness/Scaling/Roughness
    Description
    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
    Time Frame
    Baseline, Day 14, Day 30, Day 60
    Title
    Clinician Evaluator assessment of change of improvement using the expert grading scale for Luminosity
    Description
    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
    Time Frame
    Baseline, Day 14, Day 30, Day 60
    Secondary Outcome Measure Information:
    Title
    Subject Self Assessment Questionnaire
    Description
    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.
    Time Frame
    Day 14, Day 30, Day 60
    Title
    Clinician Evaluator assessment of change in tolerability Stinging/Burning
    Description
    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
    Time Frame
    Baseline, Day 14, Day 30, Day 60
    Title
    Clinician Evaluator assessment of change in tolerability Itching
    Description
    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.
    Time Frame
    Baseline, Day 14, Day 30, Day 60
    Title
    Clinician Evaluator assessment of change in tolerability Tightness
    Description
    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.
    Time Frame
    Baseline, Day 14, Day 30, Day 60
    Title
    Clinician Evaluator assessment of change in tolerability Rash
    Description
    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
    Time Frame
    Baseline, Day 14, Day 30, Day 60

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: Mild to moderate confluent facial redness or blotchy redness 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. 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. 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 Retinoids and other vitamin A derivatives within 1 month 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 Systemic retinoids within 6 months Systemic tetracycline class antibiotics within 2 months Systemic macrolide antibiotics within 4 weeks 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Pacheco
    Phone
    858-657-1004
    Email
    apacheco@clderm.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Freia Canals Cistero, RN
    Phone
    8586571004
    Email
    freia.canals@westderm.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27861741
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30809947
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30803131
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs