SunburnPhase 2NCT03332524
Clinical Trial of the Safety and Efficacy of SP160412 in the Temporary Relief of Mild to Moderate Sunburn
A Phase 2 study testing SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg in people with Sunburn, run by Sephoris Pharmaceuticals LLC at 1 site in Mauritius.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sunburn
- What is being tested?
- SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMauritius
- Study dates
- 15 Jan 2018to 25 Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enter the study, a participant must meet all the following criteria:
- Male or female, with a minimum age of 18 years old.
- Participant who has experienced sunburn in the past 18 hours before inclusion in the study.
- 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.
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- 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 confirms not having used sunscreen or any other lotion on the zone of investigation before the acquired sunburn and inclusion in the study.
- 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.
- If participant is a woman of childbearing potential and declares to be sexually active, she must have a negative urine pregnancy test (UPT) at inclusion and agree to use an effective form of birth control for the duration of the study (e.g., stable dose of oral contraceptives for at least three months before the start of the study, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal). Abstinence is an acceptable form of birth control for participants who are sexually active.
Who cannot join
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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.
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- 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.
- Participant who has received sunburn or other erythematous skin reaction to light within 21 days prior to the start of the study.
- Participant with extensive body hair, tattoos or other adornment that would make clinical assessments difficult.
- Participant who is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Multicenter, Double-blinded Clinical Trial of SP160412 in the Temporary Relief of Mild to Moderate (i.e,First Degree) Sunburn
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
Read the 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
- Being tested
- SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg, 2 capsules Ibuprofen and 1 placebo, capsule Chlorpheniramine 4mg and 1 Placebo
- Keywords
- 1st degree burn
- Medical subject headings
- Sunburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mgDrug
Also called 2 Capsules Ibuprofen and one capsules Chlorpheniramine
2 Ibuprofen and capsules Chlorpheniramine maleate 3 time per day for 72 hours
2 capsules Ibuprofen and 1 placeboDrug
Also called Capsule with Ibuprofen 400 mg with Placebo
Ibuprofen and placebo
capsule Chlorpheniramine 4mg and 1 PlaceboDrug
Also called Active comparator Chlorpheniramine 4 mg with Placebo
Chlorpheniramine 4mg and one capsule Placebo 3/72days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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, Receives: 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 Receives: Drug: capsule Chlorpheniramine 4mg and 1 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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
To measure the efficacy of SP160412 on Pruritus. 11-point Itch NRS (Appendix I.3. Pruritus Numeric Rating Scale (NRS)); This instrument is presented as a single 11-point numeric scale with scores from 0 to 10, and anchored at 0 representing "No itch" and 10 representing "Worst imaginable itch"
Measured: Twice a Day (in the morning and at night) from day 1 to day 5
To measure the efficacy of SP160412 for sleep quality
To measure the Sleep quality Scale using The 11-point(NRS)) is an unidimensional patient reported outcome (PRO) for quality of sleep. Participants will on a 11-point numeric rating scale ranging from 0 for "Best possible sleep" to 10 for "Worst possible sleep". Used on a daily basis, sleep diaries are reliable and valid instruments for capturing patient reported outcomes. The sleep quality NRS has good psychometric properties.single-item sleep quality NRS was correlated with pain.
Measured: once a day in the morning from day 1 to 5
To evaluate the number of subject with adverse events
To evaluate the Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at evaluate the safety of SP160412 relative to each component alone combined with a placebo based on the incidence of treatment emergent Adverse Events will be recorded in the daily log by the participant and it will be documented at all evaluation visits. Overall incidence of adverse events will be collected for all days of evaluation, from Visit 0 (Day 0) to Visit 6 (Day 8).
Measured: once a day from Days 2 to 8
Measurement of the evolution of erythema as measured by the Chromameter
To measure the evolution of erythema color by the use of a Chromameter
Measured: at day one and visit at day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Jan 2018
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Why it stopped: Sponsor decided to stop for lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sephoris Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gitanjali Petkar, M.D, Principal investigator, C.I.D.P
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332524
- Sponsor's protocol ID
- 16CMCL249
- Status last verified
- Sep 2019
- First submitted
- 2 Oct 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter, Double-blinded Clinical Trial of SP160412 in the Temporary Relief of Mild to Moderate (i.e,First Degree) Sunburn
- ClinicalTrials.gov ID
- NCT03332524
- Acronym / sponsor ID
- 16CMCL249
- Conditions
- Sunburn
- Keywords
- 1st degree burn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to stop for lack of efficacy
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sephoris Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Product SP160412 | Experimental | Drug: SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mgoral 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. |
| capsules Ibuprofen&placebo | Placebo comparator | Drug: 2 capsules Ibuprofen and 1 placebo2 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, |
| Capsule Chlorpheniramin&placebo | Placebo comparator | Drug: capsule Chlorpheniramine 4mg and 1 Placebocapsule Chlorpheniramine 4mg and 1 Placebo, 3/72 hours-period from first dose to last dose, oral route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- enter the study, a participant must meet all the following criteria:
Key exclusion criteria (18 listed)
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mgAlso: 2 Capsules Ibuprofen and one capsules Chlorpheniramine2 Ibuprofen and capsules Chlorpheniramine maleate 3 time per day for 72 hours | Drug | Arm 1 Product SP160412 |
| 2 capsules Ibuprofen and 1 placeboAlso: Capsule with Ibuprofen 400 mg with PlaceboIbuprofen and placebo | Drug | capsules Ibuprofen&placebo |
| capsule Chlorpheniramine 4mg and 1 PlaceboAlso: Active comparator Chlorpheniramine 4 mg with PlaceboChlorpheniramine 4mg and one capsule Placebo 3/72days | Drug | Capsule Chlorpheniramin&placebo |
Primary outcome
Self reported pain score on Pain Numeric Scale (NRS) at each visit
Time frame: Twice a day (in the morning and at night) from day 1 to day 5
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").
4 secondary outcomes
To measure the efficacy SP160412 combined with a placebo in the reduction of clinical sign of sunburn
Time frame: Twice a Day (in the morning and at night) from day 1 to day 5
To measure the efficacy of SP160412 for sleep quality
Time frame: once a day in the morning from day 1 to 5
To evaluate the number of subject with adverse events
Time frame: once a day from Days 2 to 8
Measurement of the evolution of erythema as measured by the Chromameter
Time frame: at day one and visit at day 5
Results and safety
The study was stopped early (reason given: Sponsor decided to stop for lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitanjali Petkar, M.D principal investigator
C.I.D.P
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg in people with Sunburn, run by Sephoris Pharmaceuticals LLC at 1 site in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decided to stop for lack of efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self reported pain score on Pain Numeric Scale (NRS) at each visit (time frame: Twice a day (in the morning and at night) from day 1 to day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.