RednessPhase 3NCT05961579
Evaluating the Efficacy and Safety of Cleanser, Serum, and Sunscreen Products for Facial Redness.
A Phase 3 study testing Barrier Renew in people with Redness, run by Goldman, Butterwick, Fitzpatrick and Groff.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Redness
- What is being tested?
- Barrier Renew
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2023to 30 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Redness
- Being tested
- Barrier Renew
- Keywords
- facial redness, red
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barrier RenewDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Barrier Renew |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline, Day 14, Day 30, Day 60
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Day 14, Day 30, Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start11 Aug 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RednessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- RoC Opco LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961579
- Sponsor's protocol ID
- ROC-Rosacea-2023
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27861741Juliandri 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.
PubMed 30809947Baldwin 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.
PubMed 30803131
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05961579
- Acronym / sponsor ID
- ROC-Rosacea-2023
- Conditions
- Redness
- Keywords
- facial redness, red
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- RoC Opco LLC
- Study start
- 11 Aug 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen. | Experimental | Drug: Barrier RenewEnrolled 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barrier RenewRoC 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 | Drug | Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen. |
Primary outcome
Clinician Evaluator assessment of change of improvement using the expert grading scale for Redness
Time frame: Baseline, Day 14, Day 30, Day 60
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
Time frame: Baseline, Day 14, Day 30, Day 60
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
Time frame: Baseline, Day 14, Day 30, Day 60
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
5 secondary outcomes
Subject Self Assessment Questionnaire
Time frame: Day 14, Day 30, Day 60
Clinician Evaluator assessment of change in tolerability Stinging/Burning
Time frame: Baseline, Day 14, Day 30, Day 60
Clinician Evaluator assessment of change in tolerability Itching
Time frame: Baseline, Day 14, Day 30, Day 60
Clinician Evaluator assessment of change in tolerability Tightness
Time frame: Baseline, Day 14, Day 30, Day 60
Clinician Evaluator assessment of change in tolerability Rash
Time frame: Baseline, Day 14, Day 30, Day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 27861741Schaller 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.
- Background: PubMed 30809947Juliandri 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.
- Background: PubMed 30803131Baldwin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Barrier Renew in people with Redness, run by Goldman, Butterwick, Fitzpatrick and Groff.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (858-657-1004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Evaluator assessment of change of improvement using the expert grading scale for Redness (time frame: Baseline, Day 14, Day 30, Day 60). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05961579, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.