PhotoallergyNCT02872220
To Test for Photo Allergy Reaction of Sunscreens
A study testing SPF 50 Y65 110 (BAY987519), SPF 50 Y51 002 (BAY987519) and SPF 15 V27 104 (BAY987519) in people with Photoallergy, run by Bayer at 1 site in United States.
Trial summary
The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Photoallergy
- What is being tested?
- SPF 50 Y65 110 (BAY987519), SPF 50 Y51 002 (BAY987519) and SPF 15 V27 104 (BAY987519)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2015to 8 May 2015
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women, aged 18 to 65 with good general health
- Fitzpatrick skin type I IV
- Females (of childbearing potential) on acceptable measure of contraception
- Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
- Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study to Assess the Potential for Photoallergy of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27 104 in Human Subjects
The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.
- Conditions
- Photoallergy
- Being tested
- SPF 50 Y65 110 (BAY987519), SPF 50 Y51 002 (BAY987519), SPF 15 V27 104 (BAY987519), Sodium chloride [NaCl]
- Medical subject headings
- Dermatitis, Photoallergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPF 50 Y65 110 (BAY987519)Drug
Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
SPF 50 Y51 002 (BAY987519)Drug
Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
SPF 15 V27 104 (BAY987519)Drug
Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
Sodium chloride [NaCl]Drug
Negative control (200 µL, 0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).
| Study group | Role | What they receive |
|---|---|---|
| SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 | Experimental | All test products compared to that of a negative control [0.9% NaCl] were tested simultaneously on each subject. Receives: Drug: SPF 50 Y65 110 (BAY987519); Drug: SPF 50 Y51 002 (BAY987519); Drug: SPF 15 V27 104 (BAY987519); Drug: Sodium chloride [NaCl] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of inflammatory responses
Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)
Measured: up to 3 weeks
Evaluation of superficial effects
Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin
Measured: up to 3 weeks
Secondary outcomes (1)
Adverse event collection as a measure of safety and tolerability
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start23 Mar 2015
- Primary completion8 May 2015
- Study completion8 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoallergyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872220
- Sponsor's protocol ID
- 18291
- Status last verified
- Dec 2018
- First submitted
- 14 Jun 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Assess the Potential for Photoallergy of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27 104 in Human Subjects
- ClinicalTrials.gov ID
- NCT02872220
- Acronym / sponsor ID
- 18291
- Conditions
- Photoallergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 8 May 2015 (actual)
- Study completion
- 8 May 2015 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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.
The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 | Experimental | Drug: SPF 50 Y65 110 (BAY987519), Drug: SPF 50 Y51 002 (BAY987519), Drug: SPF 15 V27 104 (BAY987519), Drug: Sodium chloride [NaCl]All test products compared to that of a negative control [0.9% NaCl] were tested simultaneously on each subject. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women, aged 18 to 65 with good general health
- Fitzpatrick skin type I IV
- Females (of childbearing potential) on acceptable measure of contraception
- Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
- Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SPF 50 Y65 110 (BAY987519)Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. | Drug | SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 |
| SPF 50 Y51 002 (BAY987519)Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. | Drug | SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 |
| SPF 15 V27 104 (BAY987519)Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. | Drug | SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 |
| Sodium chloride [NaCl]Negative control (200 µL, 0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB). | Drug | SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 |
Primary outcome
Evaluation of inflammatory responses
Time frame: up to 3 weeks
Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)
Evaluation of superficial effects
Time frame: up to 3 weeks
Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin
1 secondary outcome
Adverse event collection as a measure of safety and tolerability
Time frame: up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPF 50 Y65 110 (BAY987519), SPF 50 Y51 002 (BAY987519) and SPF 15 V27 104 (BAY987519) in people with Photoallergy, run by Bayer at 1 site in United States.
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 5 inclusion and 0 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: finished, as of the sponsor's last update on 12 Dec 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of inflammatory responses (time frame: up to 3 weeks). The study lists 2 primary outcomes in all. 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 12 Dec 2018.