![Page 1: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/1.jpg)
Evaluation of a Prescription Strength Hydroquinone/L-Ascorbic Acid Treatment
System for Normal to Oily Skin
Suzanne Bruce, MD
Houston, TX
Supported by OMP, Inc.
P802
JoAnne Watson, DPM
Long Beach, CA
![Page 2: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/2.jpg)
Background•
With photodamaged skin, early intervention is important for:–
Improving the appearance of the skin
–
Minimizing the need for future treatment by encouraging skin care and protection at a young age
•
Mild photodamage can be improved by:–
Hydroquinone (reduces hyperpigmentation)
–
L-ascorbic acid (has antioxidant activity, is essential for collagen synthesis, and reduces melanin synthesis)
•
4% hydroquinone (prescription strength) is quicker and more effective than over-the-counter concentrations (up to 2%)
![Page 3: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/3.jpg)
Introduction
•
A 4% hydroquinone (HQ)/10% L-ascorbic acid treatment system has been developed to:–
Treat early signs of photodamage in youthful looking skin
–
Help prevent further photodamage
•
Two versions, for:–
Normal to dry skin (original version)
–
Normal to oily skin (newly available)
![Page 4: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/4.jpg)
Objective
•
To evaluate the 4% HQ/10% L-ascorbic acid treatment system for normal to oily skin in individuals with minimal or mild facial photodamage and hyperpigmentation
![Page 5: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/5.jpg)
Main Inclusion Criteria
•
18-40 years old•
Normal to oily facial skin with:–
Photodamage (minimal or mild)
–
Hyperpigmentation (minimal or mild intensity)•
Glogau photodamage type I or II
![Page 6: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/6.jpg)
Treatment Regimen
•
Prescription strength HQ/L-ascorbic acid treatment system for normal to oily skin used for 12 weeks
•
System composed of:1.
Cleansing gel (twice daily)
2.
Balancing toner (twice daily)3.
Clarifying serum (each morning)
4.
Sunscreen SPF 30 (each morning and as needed)5.
Night cream (each evening)
![Page 7: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/7.jpg)
Ingredients in Treatment System
• 4% hydroquinone• 10% L-ascorbic acid• Vitamin E• Witch hazel• Aloe barbadensis leaf juice• Proprietary penetrating ingredients• Micronized zinc oxide• Octinoxate
![Page 8: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/8.jpg)
•
Overall integrated assessment, fine lines and wrinkles, tactile roughness, laxity–
None, minimal, mild, mild up to moderate, moderate, severe
•
Overall intensity of pigmentation–
None, minimal, mild 2, mild 3, moderate, marked, severe
•
Global improvement–
0%, ~10%, ~25%, ~50%, ~75%, ~90%, ~100% improvement
•
Lightness/brightness of skin–
0%, ~10%, ~25%, ~50%, ≥
~75% increase
Investigator Evaluations
![Page 9: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/9.jpg)
Patient Evaluations
•
Smoothness of skin •
Softness of skin
•
Evenness of skin tone•
Radiance of skin
•
Visible reduction in fine lines and wrinkles •
Efficacy of HQ/L-ascorbic acid system
•
Improvement in overall appearance of skin•
Satisfaction with overall appearance of skin
•
Ease of application of HQ/L-ascorbic acid system•
Comparison with previous skin care treatments
![Page 10: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/10.jpg)
Results
•
34 patients enrolled:–
30 (88%) completed
–
4
discontinued (3 due to mild adverse events, 1 due to voluntary withdrawal)
•
Mean age of 32 years•
82% Caucasian, 12% Asian, 6% black
•
Majority (88%) were Fitzpatrick skin type II-IV •
Glogau photodamage classification:̶ 27% type I̶ 74% type II
![Page 11: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/11.jpg)
Clinical Improvement
Baseline
Week 4 Week 12
![Page 12: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/12.jpg)
Clinical Improvement
Baseline
Week 4 Week 12
![Page 13: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/13.jpg)
Clinical Improvement
Baseline
Week 4 Week 12
![Page 14: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/14.jpg)
Clinical Improvement
Baseline
Week 4 Week 12
![Page 15: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/15.jpg)
Investigator Evaluations
![Page 16: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/16.jpg)
Overall Integrated Assessment of Photodamage
0
20
40
60
80
100
Week 4 Week 6 Week 12
Patients with at least 1-grade improvement from baseline
(%)
7%
47%
80%
***
***
*** P≤.001 for median score versus baseline
![Page 17: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/17.jpg)
Overall Intensity of Pigmentation
0
20
40
60
80
100
Week 4 Week 6 Week 12
Patients with at least 1-grade improvement from baseline
(%) 30%
60%
87%
**
***
***
** P≤.01, *** P≤.001 for median score versus baseline
![Page 18: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/18.jpg)
Fine Lines and Wrinkles
0
20
40
60
80
100
Week 4 Week 6 Week 12
Patients with at least 1-grade improvement from baseline
(%)
10%
30%
50%
**
***
** P≤.01, *** P≤.001 for median score versus baseline
![Page 19: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/19.jpg)
Tactile Roughness
0
20
40
60
80
100
Week 4 Week 6 Week 12
Patients with at least 1-grade improvement from baseline
(%)
57%
87% 90%*** ***
***
*** P≤.001 for median score versus baseline
![Page 20: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/20.jpg)
Laxity
0
20
40
60
80
100
Week 4 Week 6 Week 12
Patients with at least 1-grade improvement from baseline
(%)
7% 10%
33%*
* P≤.05 for median score versus baseline
![Page 21: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/21.jpg)
Incidence of ≥
50% Global Improvement
0
20
40
60
80
100
Week 12
Moderate improvement(~50% improvement)Marked improvement (~75% improvement)Almost complete clearing(~90% improvement)Complete clearing (100% improvement)
Patients (%)
90%
![Page 22: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/22.jpg)
Incidence of ≥
50% Increase in Lightness/Brightness of Facial Skin
0
20
40
60
80
100
Week 12
Moderate increase (~50%)
Marked increase (≥ ~75%)Patients
(%)
87%
![Page 23: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/23.jpg)
Patient Evaluations
![Page 24: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/24.jpg)
Patient Ratings of Improvement at Week 12
0
20
40
60
80
100
Somewhat agreeStrongly agree
Patients (%)
97%87%
Skin appears
more radiant
Visible reduction in fine lines &
wrinkles
Skin texture
smoother
Skin more
evenly toned
Skin feels softer
90%93% 90%
![Page 25: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/25.jpg)
Efficacy of HQ/L-Ascorbic Acid Treatment System
0
20
40
60
80
100
Week 4 Week 6 Week 12
GoodVery goodExcellentPatients
(%)
83% 87%97%
![Page 26: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/26.jpg)
Improvement in Overall Appearance of Skin
0
20
40
60
80
100
Week 4 Week 6 Week 12
Moderately improvedVery improvedExtremely improvedPatients
(%)
80%90%
97%
![Page 27: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/27.jpg)
Satisfaction with Overall Appearance of Skin
0
20
40
60
80
100
Week 4 Week 6 Week 12
Satisfied
Very satisfiedPatients (%)
90% 87%100%
![Page 28: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/28.jpg)
HQ/L-Ascorbic Acid Treatment System is Easy to Apply
0
20
40
60
80
100
Week 4 Week 6 Week 12
Somewhat agree
Strongly agreePatients (%)
90% 93% 93%
![Page 29: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/29.jpg)
Comparison of Study System with Other Skin Care Treatments Used Previously
0
20
40
60
80
100
Week 4 Week 6 Week 12
GoodVery goodExcellentPatients
(%)
83% 87%100%
![Page 30: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/30.jpg)
Efficacy Summary•
The HQ/L-ascorbic acid system was associated with improvements in:–
Fine lines and wrinkles–
Tactile roughness –
Laxity–
Intensity of pigmentation–
Evenness of skin tone–
Lightness/brightness of the skin–
Smoothness of the skin–
Softness of the skin–
Radiance of the skin–
Overall appearance of the skin•
93% patients reported the HQ/L-ascorbic acid system was easy to apply •
100% patients were satisfied with the overall appearance of their skin•
100% patients reported the system was good, very good, or excellent compared with other skin treatments they had used
before
![Page 31: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/31.jpg)
Tolerability•
Adverse events at least probably related to treatment:–
Dryness (32%)–
Erythema (9%)–
Peeling (9%)–
Pruritus (6%)–
Milia (6%)–
Rash (3%)–
Burning sensation (3%)–
Contact dermatitis (3%)–
Acne (3%)•
3 discontinuations due to mild facial adverse events:–
Dryness–
Erythema, pruritus, dryness, rash–
Contact dermatitis
![Page 32: Evaluation of a Prescription Strength Hydroquinone/Vitamin C Treatment … · Minimizing the need for future treatment by encouraging skin care and protection at a young age ... 4%](https://reader034.vdocuments.mx/reader034/viewer/2022052001/60132bf41b5bcb3c3c013d39/html5/thumbnails/32.jpg)
Conclusion•
The prescription strength HQ/L-ascorbic acid treatment system can help to ameliorate early signs of photodamage in normal to oily skin including:–
Fine lines and wrinkles
–
Tactile roughness–
Laxity
–
Hyperpigmentation and unevenness of skin tone•
At week 12, 100% of patients were satisfied or very satisfied with the overall appearance of their skin
•
The system is easy to apply and compares favorably with other skin treatments patients have used previously