A Phase 3 interventional study of Barrier Renew in Redness, sponsored by Goldman, Butterwick, Fitzpatrick and Groff. Not yet recruiting. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Goldman, Butterwick, Fitzpatrick and Groff · Phase 3, Interventional, and Treatment
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.
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.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →Goldman, Butterwick, Fitzpatrick and Groff is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At the baseline evaluation, all subjects must exhibit all of the following:
For female subjects of , must be willing to use an acceptable form of 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.
Exclusion Criteria:
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
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, , antifungals, antimicrobials or acne medications for two weeks prior to study start or the time period specified below
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 14, Day 30, Day 60
Subject Self Assessment Questionnaire
Agree strongly Agree Neither agree nor disagree Disagree Disagree Strongly 1. Cleanser/moisturizer helped reduce the redness of my facial skin. 2. Cleanser/moisturizer calmed and soothed my dry, irritated skin. 3. Cleanser/moisturizer helped reduce the dryness/tightness of my skin. 4. Cleanser/moisturizer helped reduce the unevenness of my skin. 5. Cleanser/moisturizer left my skin radiant/brighter. 6. Cleanser/moisturizer leaves my skin softer. 7. Cleanser/moisturizer leaves my skin smoother. 8. Cleanser/moisturizer soothes my skin. 9. Cleanser/moisturizer is gentle. 10. Cleanser/moisturizer makes my skin feel and look less sensitive. 11. Cleanser/moisturizer regimen leaves skin healthy looking. 12. Cleanser/moisturizer regimen helped reduce the flakiness of my skin. 13. Cleanser/moisturizer regimen helped skin to be less reactive. 14. This simplifies my sensitive skin/rosacea routine.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, Day 14, Day 30, Day 60
No study locations are listed for this record.
Start is estimated for Aug 2023; primary completion for Nov 2023, 2 months later.
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This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Goldman, Butterwick, Fitzpatrick and Groff