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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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