NCT03332524

Clinical Trial of the Safety and Efficacy of SP160412 in the Temporary Relief of Mild to Moderate Sunburn

Phase II Multicenter, Double-blinded Clinical Trial of SP160412 in the Temporary Relief of Mild to Moderate (i.e,First Degree) Sunburn

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Sephoris Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II multicenter, double-blinded clinical trial of the safety and efficacy of SP160412 in the temporary relief of mild to moderate, (i.e. first degree) sunburn

Detailed description

The objectives of the trial or study, its endpoints, its assumptions and its variables are described below: Objectives and endpoints Study objectives The study intends to determine and compare the safety and synergistic efficacy of the combined dosing of Ibuprofen and Chlorpheniramine maleate vs. each of the individual drugs in subjects with mild to moderate ( 1st degree) sunburn.

Conditions

• Sunburn

Interventions

Type	Name	Description
DRUG	SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg	2 Ibuprofen and capsules Chlorpheniramine maleate 3 time per day for 72 hours
DRUG	2 capsules Ibuprofen and 1 placebo	Ibuprofen and placebo
DRUG	capsule Chlorpheniramine 4mg and 1 Placebo	Chlorpheniramine 4mg and one capsule Placebo 3/72days

Timeline

• Start date: 2018-01-15
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2017-11-06
• Last updated: 2019-09-27

Locations

1 site across 1 country: Mauritius

Regulatory

• FDA-regulated drug study