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HYDRATE, the new nail-growth product by DOCTORS Kline and Green was recently involved in a blind case-study by Dr. Draelos to prove effectiveness. The topical light-weight gel formula was applied to the nail plate surface on volunteers twice daily for a length of 12 weeks. The most remarkable findings revealed a “statistically significant improvement in nail shine on the treated hand at week two. This improvement continued into week four with additional statistically significant improvements in shine and overall nail appearance.” Overall nail condition continued to improve in the following weeks of the study and by week eight the treated nails showed statistically significant superiority in nail growth, brittleness, shine, and smoothness. At the conclusion of the clinical study vast improvement was seen in NAIL GROWTH, brittleness, overall appearance, shine, and smoothness. DOCTORS Kline + Green HYDRATE proves to be efficacious for overall nail health, nail growth, nail shine and enhanced appearance.
Clinically significant results were apparent in all subjects by investigator assessments at weekly intervals. All visits consisted of a result assessment, tolerability assessment, and nail photographs. Baseline only consisted of consent, exclusion and inclusion criteria, and a brief medical history. All succeeding visits included consumer perception questionnaire, diary accountability and reviews, with a diary collection at the end of week 12.
Nail treatment was randomized by hand between the left or right option with the opposite hand serving as the control. Both studies involved only female subjects with mild to moderate nail issues. However, subjects with severe fungal, peeling or splitting/separating nail issues were eliminated from the subject pool. Subjects were also not allowed to maintain artificial nail decorations or products; however, concomitant topical and oral medications were permitted.
Study 1 involved a total of 30 female participants and check-ins with the investigator (a certified dermatologist) at week 0 (baseline), 2, 4, 8, and 12. The blinded dermatologist investigator rated each hand on a 5-point ordinal scale with assessment of aspects such as: nail smoothness, shine, growth, brittleness, peeling, lifting, and overall appearance. After being trained in the correct application of HYDRATE and proper nail assessment, unblinded subjects rated each hand and followed the process with photographs. The investigator then reviewed each subject’s compliance diary records of correct application and compared nail product usage from the previous visit.
Study 2 involved an additional 15 female participants with mild to moderate nail issues including all Fitzpatrick skin types. The screening process involved both inclusion and exclusion criteria. Inclusion criteria involved adherence to necessary standards for subject criteria (e.g., skin type on the Fitzpatrick scale I – IV, female gender, and having only mild to moderate nail issues). Exclusion criteria was measured based on any medical, physical, or psychological issues that may interfere with the study or self-assessment of nails. Nails were assessed based on both tolerability and efficacy scales from none (0) to severe (5). Tolerability scales rated skin reactions, such as burning, itching, and stinging, and efficacy scales rated the effect of the topical nail gel on factors such as nail appearance, growth rate, texture and shine.
Various efficacy endpoints were also assessed including the primary endpoint which indicated a pronounced nail Improvement after the conclusion of the 12 week study. The secondary endpoint indicated a significant and noteworthy enhancement of overall nail appearance after only 2 weeks of product application. The tolerability endpoint was also remarkable due to the absence of allergic reactions or contact dermatitis. Additionally, the safety endpoint indicated ZERO ADVERSE side effects during the study.
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