Clinical Trial Search

Primary: Percentage of Participants With Specific Grade 2 or Higher Skin Toxicities During the 6-week Skin Treatment Period — 29; 62 percentage of participants

Primary: Percentage of Participants With Photo-initiated Potential Sensitization Reaction — 0; 0; 0; 0 Participants

Primary: Number of Subjects That Showed no Significant Irritation — 0 participants

Primary: Presence of Cumulative Irritation — 163.0; 109.0; 2073.0 units on a scale

Primary: Skin Reaction Score — 0.4; 0.5; 0.1; 0.4 units on a scale

Primary: Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream…

Primary: Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40 — 2; 1; 1; 0 Number of participants

Primary: Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 2 — 0; 0 Score on scale

Primary: Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation — 110 Participants

Primary: Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale — 0 Participants

Primary: Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale — 205 participants

Primary: Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin — 1.00; 2.46; 1.34; 0.58 units on a scale

Primary: Skin Healing Time — 13.75; 19; 40.5; 34 days — p=0.01

Primary: Erythema at the Patch Test Site is Evaluated for Each Participant — 0.00; 0.59; 0.00 erythema score

Primary: Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set) — 3; 9; 6; 18 Participants

Primary: Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal — 0; 0; 0; 0 Participants

Primary: Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 3 — 0; 0 Score on scale

Primary: Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use — 1; 0; 0…

Primary: Time-averaged Effect on Radiation Dermatitis Grade Measured With Common Terminology Criteria for Adverse Events (CTCAE, v 4.03) Following 3D Conformal Radiation Therapy…

Primary: Observed Phototoxicity — 0.15; 0.15; 0.00; 0.00 Score on a scale — p=1.0000

Primary: Microcomedone Score of Follicular Biopsies — 0.84; 0.97 microcomedone score — p=0.274

Primary: Number of Participants Categorized by RTOG Grading Scale — 12; 6; 11; 11 Participants

Primary: Percentage of Participants With Moist Desquamation — 66.7; 43.8 % of participants w/moist desquamation

Primary: Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01…

Primary: Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) — 2.70; 2.41; 2.70; 2.29 units on a scale

Primary: Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates — 6.81; 18.18; 75.00 percentage of participants

Primary: Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score — 77; 10; 85; 2 Test site

Primary: Frequency of Combined Dermatologist Score — 1; 1; 51; 55 Participants

Primary: Number of Participants With a Unit Change of Greater Than (>) 1 in Signs and Symptoms of Cutaneous Irritation Total Scores From Baseline to 21 Days of Product Use — 3; 0…

Primary: Number of Participants With Progression of Radio Therapy Induced Skin Reaction — 35; 33 Participants