P802 Evaluation of a Prescription Strength Hydroquinone/L-Ascorbic Acid Treatment System for Normal to Oily Skin Suzanne Bruce, MD JoAnne Watson, DPM Houston, TX Long Beach, CA Supported by OMP, Inc.
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%)
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)
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
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
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)
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
Investigator Evaluations • 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
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
̶ ̶ 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 I 74% type II
Clinical Improvement Baseline Week 4 Week 12
Clinical Improvement Baseline Week 4 Week 12
Clinical Improvement Baseline Week 4 Week 12
Clinical Improvement Baseline Week 4 Week 12
Investigator Evaluations
Overall Integrated Assessment of Photodamage 100 *** 80% 80 Patients with at least 1-grade 60 *** improvement 47% from baseline 40 (%) 20 7% 0 Week 4 Week 6 Week 12 *** P ≤ .001 for median score versus baseline
Overall Intensity of Pigmentation 100 *** 87% 80 Patients with at *** 60% least 1-grade 60 improvement from baseline ** 40 (%) 30% 20 0 Week 4 Week 6 Week 12 ** P ≤ .01, *** P ≤ .001 for median score versus baseline
Fine Lines and Wrinkles 100 80 Patients with at least 1-grade *** 60 50% improvement from baseline ** 40 (%) 30% 20 10% 0 Week 4 Week 6 Week 12 ** P ≤ .01, *** P ≤ .001 for median score versus baseline
Tactile Roughness *** 100 *** 90% 87% 80 Patients with at *** least 1-grade 57% 60 improvement from baseline 40 (%) 20 0 Week 4 Week 6 Week 12 *** P ≤ .001 for median score versus baseline
Laxity 100 80 Patients with at least 1-grade 60 improvement from baseline * 40 33% (%) 20 10% 7% 0 Week 4 Week 6 Week 12 * P ≤ .05 for median score versus baseline
Incidence of ≥ 50% Global Improvement 100 90% Moderate improvement 80 (~50% improvement) Patients (%) Marked improvement 60 (~75% improvement) Almost complete clearing 40 (~90% improvement) Complete clearing (100% improvement) 20 0 Week 12
Incidence of ≥ 50% Increase in Lightness/Brightness of Facial Skin 100 87% Moderate increase (~50%) 80 Patients Marked increase ( ≥ ~75%) (%) 60 40 20 0 Week 12
Patient Evaluations
Patient Ratings of Improvement at Week 12 100 97% 93% 90% 90% 87% 80 Patients Somewhat agree (%) Strongly agree 60 40 20 0 Skin Skin Skin Skin Visible feels more appears reduction in texture more smoother softer evenly fine lines & toned radiant wrinkles
Efficacy of HQ/L-Ascorbic Acid Treatment System 97% 100 87% 83% Good 80 Very good Patients Excellent 60 (%) 40 20 0 Week 4 Week 6 Week 12
Improvement in Overall Appearance of Skin 97% 100 90% 80% Moderately improved 80 Very improved Patients Extremely improved 60 (%) 40 20 0 Week 4 Week 6 Week 12
Satisfaction with Overall Appearance of Skin 100% 100 90% 87% 80 Satisfied Patients Very satisfied 60 (%) 40 20 0 Week 4 Week 6 Week 12
HQ/L-Ascorbic Acid Treatment System is Easy to Apply 100 93% 93% 90% 80 Somewhat agree Patients Strongly agree 60 (%) 40 20 0 Week 4 Week 6 Week 12
Comparison of Study System with Other Skin Care Treatments Used Previously 100% 100 87% 83% Good 80 Very good Patients Excellent 60 (%) 40 20 0 Week 4 Week 6 Week 12
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
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
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
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