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

NCT03332524 | Terminated Phase 2 FDA Drug

• 1 other identifier: 16CMCL249
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

1st degree burn

Outcome Measures

Primary Outcomes (1)

• Self reported pain score on Pain Numeric Scale (NRS) at each visit

  To measure the efficacy of SP160412 in the reduction of pain as reported by the participants. The Brief Pain Inventory - short version assesses pain in the last 24 hours and its impact on daily functioning. It evaluates the worst, the least, the average pain the participants felt during the last day and the actual pain. Scores range from 0 ("no pain") to 10 ("pain as bad as you can imagine"). BPI also evaluates the degree to which pain has interfered with different areas of participants' lives over the past 24 hours: general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven interference items, each of which is scored from zero ("does not interfere") to 10 ("completely interferes"). Finally, BPI also evaluates the amount of relief of pain treatments have provided in the past 24 hours, ranging from 0% ("no relief") to 100% ("complete relief").

  Twice a day (in the morning and at night) from day 1 to day 5

Secondary Outcomes (4)

• To measure the efficacy SP160412 combined with a placebo in the reduction of clinical sign of sunburn

  Twice a Day (in the morning and at night) from day 1 to day 5

• To measure the efficacy of SP160412 for sleep quality

  once a day in the morning from day 1 to 5

• To evaluate the number of subject with adverse events

  once a day from Days 2 to 8

• Measurement of the evolution of erythema as measured by the Chromameter

  at day one and visit at day 5

Study Arms (3)

Arm 1 Product SP160412

EXPERIMENTAL

oral route, 9 doses (Capsule) of SP160412 (Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg combined) in the 72 hours-period from first dose to last dose.

Drug: SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg

capsules Ibuprofen&placebo

PLACEBO COMPARATOR

2 capsules Ibuprofen and 1 placebo, oral route, 9 doses of Ibuprofen 400 mg with Placebo (Capsule) in the 72 hours-period from first dose to last dose,

Drug: 2 capsules Ibuprofen and 1 placebo

Capsule Chlorpheniramin&placebo

PLACEBO COMPARATOR

capsule Chlorpheniramine 4mg and 1 Placebo, 3/72 hours-period from first dose to last dose, oral route

Drug: capsule Chlorpheniramine 4mg and 1 Placebo

Interventions

SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg DRUG

2 Ibuprofen and capsules Chlorpheniramine maleate 3 time per day for 72 hours

Also known as: 2 Capsules Ibuprofen and one capsules Chlorpheniramine

Arm 1 Product SP160412

2 capsules Ibuprofen and 1 placebo DRUG

Ibuprofen and placebo

Also known as: Capsule with Ibuprofen 400 mg with Placebo

capsules Ibuprofen&placebo

capsule Chlorpheniramine 4mg and 1 Placebo DRUG

Chlorpheniramine 4mg and one capsule Placebo 3/72days

Also known as: Active comparator Chlorpheniramine 4 mg with Placebo

Capsule Chlorpheniramin&placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enter the study, a participant must meet all the following criteria:
• Male or female, with a minimum age of 18 years old.
• Participant who is willing and able to give written informed consent and understand the language used at the investigation site.
• Participant who is willing and able to administer the investigational medicinal product (IMP) as directed, comply with study instructions and commit to all the follow-up visits for the duration of the study.
• Participant with a Fitzpatrick skin type I, II or III as clinically defined by the investigator.
• Participant with a clinical assessment of sunburn score of 2 (mild) or 3 (moderate) according to clinical grading described in Appendix II.2. Clinical Assessment of Sunburn (page 78).
• Participant who is in good general health and free of any disease state or physical condition except sunburn that might impair the clinical evaluation of erythema, pain and pruritus associated with sunburn.
• Participant who agrees not to expose themself further to the sun and not to apply any topical product (sunscreen, aftersun products, products containing aloe vera, moisturizing products…) on the zone of investigation within 18 hours before sunburn and during the study.

You may not qualify if:

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• Participant who routinely subjects himself/herself to natural or artificial tanning or the like which, in the investigator's opinion, exposes the participant to an unacceptable risk when taking part in the study.
• Participant who is pregnant or lactating, or is planning to become pregnant during the study.
• Participant who is currently enrolled in an investigational product or device study.
• Participant who has used an investigational product or investigational device treatment within 30 days prior to the start of the study.
• Participant with a medical condition (including previous history of cardiac disease, renal disease, gastrointestinal bleeding, uncontrolled hypertension) or a medication which, in the clinical investigator's judgement, makes the participant ineligible or places the participant at undue risk during the study.
• Participant who has a history of drug allergy or sensitivity to NSAIDs, including Aspirin, and/or to Chlorpheniramine maleate, and/or to any of the components of the IMP.
• Participant who has used pain relieving and/or analgesic medications (e.g. NSAIDs, ASA, opiates, Tramadol, arnica, products containing aloe vera) or psychoactive substances (e.g. marijuana) within 7 days before the start of the study.
• Participant who has used any topical or oral antihistamine/anti-allergy medications within 7 days prior to the start of the study.
• Participant who has used any photosensitizing medication (e.g., topical or systemic retinoids, tetracycline or derivatives, etc.) within 30 days of the start of the study. Estrogens as part of birth control agents or hormone replacement therapy are allowed.
• Participant with acute or chronic pain condition.
• Participant suffering from asthma.
• Participant who has a history of any light-sensitive disorder including but not limited to lupus erythematosus, polymorphous light eruption or porphyria.
• Participant with a personal or family history in a first-degree relative of malignant melanoma, dysplastic nevi or non-melanoma skin cancer.
• Participant who has received more than one sunburn in the last 6 months in the same zone as the study sunburnt evaluation zone.

Sponsors & Collaborators

• Sephoris Pharmaceuticals LLC: lead

Study Sites (1)

CIDP

Phoenix, 73408, Mauritius

Location

MeSH Terms

Conditions

Sunburn

Interventions

Chlorpheniramine; Ibuprofen

Condition Hierarchy (Ancestors)

Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Burns; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Gitanjali Petkar, M.D

  C.I.D.P

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-centers double-blinded clinical trial with one intervention arm with SP160412 (Ibuprofen and Chlorpheniramine combined) with one arm with Active control (Ibuprofen with placebo) and a third arm (Chlorpheniramine with Placebo)

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: November 6, 2017
• Study Start: January 15, 2018
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)