Prescription & OTC Drugs – Carla Maria dos Santos Vozone, Mohammad Salman, George Nathaniel Magrath, Courtney Rouse Smith, Hovione Scientia Ltd

Abstract for “Methods of treating rosacea with compositions”

“The invention contains methods, compositions and kits that contain a minocycline topal suspension for treating rosacea.”

Background for “Methods of treating rosacea with compositions”

“BRIEF DESCRIPTION ABOUT FIGURES”

“Definitions”

“I. “I.

“A. “A.

“B. “B.

“C. Third Method.”

“D. Fourth Method.”

“E. Fifth Method”

“F. Sixth Method.”

“G. Seventh Method.”

“H. Additional Exemplary Characteristics of the Second through Seventh Therapeutic Methods”

“Dosage of Minocycline Topical Subspension”

“Amount of Minocycline In the Topical Suspension.”

“Materials in Polymeric Hydrocarbon Gelling Agent

“Particle Size of Minocycline Particles.”

“Patients for Treatment”

“I. Additional Exemplary Features of the First through Seventh Therapeutic Methods

“1. Minocycline Topical Subspension

“Form of Minocycline.”

“Particle Size of Minocycline Particles.”

“Polymeric Hydrocarbon Gelling agent”

“Liquid Medium”

“Stability and Suspension of Minocycline Topical”

“Sterility level of the Minocycline Topical Subspension”

“Non-Newtonian Physical Property”

“Exemplary more Specific Embodiments”

“2. “2.

“Timing for Administration.”

“Location to Administration”

“Removing Minocycline Topical Subspension”

“Duration of Treatment.”

“4. “4.

“Reduction of Inflammatory Lesions.”

“Reduction of Erythema Severity Score

“Reduction of Telangiectasia Severity Score”

“Time to Achieve and Duration of Reductions”

“Improvements to Investigators Global Assessment Score”

“Limited Undesirable Side Effects”

“Systemic Minocycline Exposition?Blood Plasma Pharmacokinetic parameters”

“Reduction of Transepidermal water Loss”

“Increase in water content of patient’s skin”

“J. “J.

“II. “II.

“III. “III. Preparation of a Medicament

“IV. “IV.

“EXAMPLES”

“Example 1?” Preparation of Minocycline Topical Subspension

“Example 2?” Stability Study of 3% with Minocycline Topical Subspension

“Part I?Experimental Procedures”

“Part II?Results”

“Example 3?” Stability Study of 1% with Minocycline Topical Subspension

“Part I?Experimental Procedures”

“Part II?Results”

“Example 4: Treatment of Papulopustular Rosacea by Human Subjects Using Minocycline Topical Subspension”

“A. “A.

“B. Investigational Product(IP)”

“C. Study Objectives & Endpoints”

“D. Study Eligibility Criteria.”

“Withdrawal” and “Early Discontinuation”

“Contraception and Pregnancy Avoidance measures”

“Prior, Concomitant and Prohibited Therapy”

“E. Study Procedures.”

“Treatment Assignment (Randomization).”

“Blinding”

“Study Drug Dispensation & Application”

“Treatment Compliance”

“Documentation Screen Failures”

“Clinical Evaluations”

“Subject Demographics”

“Medical History”

“Concomitant Medication Recording”

“Vital Signs”

“Physical Examination”

“Recording Inflammatory Lesions Counts”

“Investigator’s Global Assessment” (IGA).

“Erythema severity score”

“Telangiectasia Severity Scoring”

“Safety and Tolerability Assessments.”

“Assessment for Adverse Events”

“Local Application Skin Response Score”

“Skin discoloration score”

“Subject’s Self-Assessment Questionnaire”

“Subject’s Investigation Site visits”

“F. Safety Data Recording, Collection, and Reporting”

“G. Data Analysis.”

“Subject Population/Data sets to be Evaluated”

“Efficacy Assessments”

“Safety Assessments”

“Exploratory Endpoints”

“Part II?Results”

“Demographics”

“Inflammatory Lesions”

“Investigators Global Analysis (IGA).”

“Erythema severity score”

“Subject Satisfaction & Safety”

“Pharmacokinetic Evaluation”

“Conclusions”

“Example 5: Treatment of Papulopustular Rosacea in Human Subjects Using 3% w/w Minicycline Topical Subspension

“A. “A.

“B. “B.

Summary for “Methods of treating rosacea with compositions”

“BRIEF DESCRIPTION ABOUT FIGURES”

“Definitions”

“I. “I.

“A. “A.

“B. “B.

“C. Third Method.”

“D. Fourth Method.”

“E. Fifth Method”

“F. Sixth Method.”

“G. Seventh Method.”

“H. Additional Exemplary Characteristics of the Second through Seventh Therapeutic Methods”

“Dosage of Minocycline Topical Subspension”

“Amount of Minocycline In the Topical Suspension.”

“Materials in Polymeric Hydrocarbon Gelling Agent

“Particle Size of Minocycline Particles.”

“Patients for Treatment”

“I. Additional Exemplary Features of the First through Seventh Therapeutic Methods

“1. Minocycline Topical Subspension

“Form of Minocycline.”

“Particle Size of Minocycline Particles.”

“Polymeric Hydrocarbon Gelling agent”

“Liquid Medium”

“Stability and Suspension of Minocycline Topical”

“Sterility level of the Minocycline Topical Subspension”

“Non-Newtonian Physical Property”

“Exemplary more Specific Embodiments”

“2. “2.

“Timing for Administration.”

“Location to Administration”

“Removing Minocycline Topical Subspension”

“Duration of Treatment.”

“4. “4.

“Reduction of Inflammatory Lesions.”

“Reduction of Erythema Severity Score

“Reduction of Telangiectasia Severity Score”

“Time to Achieve and Duration of Reductions”

“Improvements to Investigators Global Assessment Score”

“Limited Undesirable Side Effects”

“Systemic Minocycline Exposition?Blood Plasma Pharmacokinetic parameters”

“Reduction of Transepidermal water Loss”

“Increase in water content of patient’s skin”

“J. “J.

“II. “II.

“III. “III. Preparation of a Medicament

“IV. “IV.

“EXAMPLES”

“Example 1?” Preparation of Minocycline Topical Subspension

“Example 2?” Stability Study of 3% with Minocycline Topical Subspension

“Part I?Experimental Procedures”

“Part II?Results”

“Example 3?” Stability Study of 1% with Minocycline Topical Subspension

“Part I?Experimental Procedures”

“Part II?Results”

“Example 4: Treatment of Papulopustular Rosacea by Human Subjects Using Minocycline Topical Subspension”

“A. “A.

“B. Investigational Product(IP)”

“C. Study Objectives & Endpoints”

“D. Study Eligibility Criteria.”

“Withdrawal” and “Early Discontinuation”

“Contraception and Pregnancy Avoidance measures”

“Prior, Concomitant and Prohibited Therapy”

“E. Study Procedures.”

“Treatment Assignment (Randomization).”

“Blinding”

“Study Drug Dispensation & Application”

“Treatment Compliance”

“Documentation Screen Failures”

“Clinical Evaluations”

“Subject Demographics”

“Medical History”

“Concomitant Medication Recording”

“Vital Signs”

“Physical Examination”

“Recording Inflammatory Lesions Counts”

“Investigator’s Global Assessment” (IGA).

“Erythema severity score”

“Telangiectasia Severity Scoring”

“Safety and Tolerability Assessments.”

“Assessment for Adverse Events”

“Local Application Skin Response Score”

“Skin discoloration score”

“Subject’s Self-Assessment Questionnaire”

“Subject’s Investigation Site visits”

“F. Safety Data Recording, Collection, and Reporting”

“G. Data Analysis.”

“Subject Population/Data sets to be Evaluated”

“Efficacy Assessments”

“Safety Assessments”

“Exploratory Endpoints”

“Part II?Results”

“Demographics”

“Inflammatory Lesions”

“Investigators Global Analysis (IGA).”

“Erythema severity score”

“Subject Satisfaction & Safety”

“Pharmacokinetic Evaluation”

“Conclusions”

“Example 5: Treatment of Papulopustular Rosacea in Human Subjects Using 3% w/w Minicycline Topical Subspension

“A. “A.

“B. “B.

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