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

NCT05961579 | Unknown Phase 3

• 1 other identifier: ROC-Rosacea-2023
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Redness

Keywords

facial redness; red

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (5)

• Subject Self Assessment Questionnaire

  Day 14, Day 30, Day 60

• Clinician Evaluator assessment of change in tolerability Stinging/Burning

  Baseline, Day 14, Day 30, Day 60

• Clinician Evaluator assessment of change in tolerability Itching

  Baseline, Day 14, Day 30, Day 60

• Clinician Evaluator assessment of change in tolerability Tightness

  Baseline, Day 14, Day 30, Day 60

• Clinician Evaluator assessment of change in tolerability Rash

  Baseline, Day 14, Day 30, Day 60

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Barrier Renew DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• RoC Opco LLC: collaborator

Related Publications (3)

• 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.

  PMID: 27861741 BACKGROUND

• 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.

  PMID: 30809947 BACKGROUND

• 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.

  PMID: 30803131 BACKGROUND

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andrea Pacheco

CONTACT

858-657-1004; apacheco@clderm.com

Freia Canals Cistero, RN

CONTACT

8586571004; freia.canals@westderm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: August 11, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 30, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-07