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

NCT03332524 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-09-27

No results posted yet for this study

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

Conditions

  • Sunburn

Interventions

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

Sponsors & Collaborators

  • Sephoris Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Gitanjali Petkar, M.D · C.I.D.P

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2019-09-25
Completion
2019-09-25
FDA Drug
Yes

Countries

  • Mauritius

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332524 on ClinicalTrials.gov