Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected SkinNCT02251756
Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
A study testing Actinica, 0.8 mg/cm2, 1 application, Actinica, 0.8 mg/cm2, 2 applications and Actinica, 2 mg/cm2, 1 application in people with Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin, run by Galderma R&D at 1 site in France.
Trial summary
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III). Study centers A total of 20 subjects will be enrolled in 1 site in France. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin
- What is being tested?
- Actinica, 0.8 mg/cm2, 1 application, Actinica, 0.8 mg/cm2, 2 applications and Actinica, 2 mg/cm2, 1 application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Jul 2014
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18-60 years of age,
- Subject with Phototype I, II or III,
- Subject with individual typology angle (ITA) 28-70°,
- Subject with healthy skin / not tanned on the back,
Who cannot join
- 1. Subject with obvious skin cancer forms within the test areas, 2. Subject with hairs on the treated area that might interfere with clinical investigation assessments, 3. Subjects who have performed sun bathing at least four months before enrolment, 10. History of sun allergy / Mallorca acne, active photo induced or photo aggravated disease, or abnormal response to the sun (e.g., photosensitive dermatoses, polymorphic light eruption, solar urticaria, systemic lupus erythematosus, or dermatomyositis).
- 11. The subject has received, applied or taken the forbidden treatments within the specified time frame prior to the Day 0 visit (list available on request)
Trial locations and contacts
1 site in 1 country.
About this study
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).
Study centers A total of 20 subjects will be enrolled in 1 site in France.
Read more
Methodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation.
There will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days.
Study population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria.
The clinical investigation will be conducted in 2 parts.
Part 1 - SPF determination:
To determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2).
Part 2 - Sun exposure:
To assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.
- Being tested
- Actinica, 0.8 mg/cm2, 1 application, Actinica, 0.8 mg/cm2, 2 applications, Actinica, 2 mg/cm2, 1 application, Actinica, 2 mg/cm2, 2 applications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actinica, 0.8 mg/cm2, 1 applicationDevice
Actinica, 0.8 mg/cm2, 2 applicationsDevice
Actinica, 2 mg/cm2, 1 applicationDevice
Actinica, 2 mg/cm2, 2 applicationsDevice
| Study group | Role | What they receive |
|---|---|---|
| Actinica, 0.8 mg/cm2, 1application | Experimental | Actinica, 0.8 mg/cm2, 1application over one day of sun exposure Receives: Device: Actinica, 0.8 mg/cm2, 1 application |
| Actinica, 0.8 mg/cm2, 2 applications | Experimental | Actinica, 0.8 mg/cm2, 2 applications over one day of sun exposure Receives: Device: Actinica, 0.8 mg/cm2, 2 applications |
| Actinica, 2 mg/cm2, 1 application | Experimental | Actinica, 2 mg/cm2, 1 application over one day of sun exposure Receives: Device: Actinica, 2 mg/cm2, 1 application |
| Actinica, 2 mg/cm2, 2 applications | Experimental | Actinica, 2 mg/cm2, 1 application over one day of sun exposure Receives: Device: Actinica, 2 mg/cm2, 2 applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
erythema score
Measured: Part 2 -Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected SkinStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251756
- Sponsor's protocol ID
- RD.03.CIP.29114
- Other IDs
- ID RCB: 2014-A00491-46
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02251756
- Acronym / sponsor ID
- RD.03.CIP.29114
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Sep 2014 (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.
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).
Study centers A total of 20 subjects will be enrolled in 1 site in France.
Methodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation.
There will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days.
Study population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria.
The clinical investigation will be conducted in 2 parts.
Part 1 - SPF determination:
To determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2).
Part 2 - Sun exposure:
To assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Actinica, 0.8 mg/cm2, 1application | Experimental | Device: Actinica, 0.8 mg/cm2, 1 applicationActinica, 0.8 mg/cm2, 1application over one day of sun exposure |
| Actinica, 0.8 mg/cm2, 2 applications | Experimental | Device: Actinica, 0.8 mg/cm2, 2 applicationsActinica, 0.8 mg/cm2, 2 applications over one day of sun exposure |
| Actinica, 2 mg/cm2, 1 application | Experimental | Device: Actinica, 2 mg/cm2, 1 applicationActinica, 2 mg/cm2, 1 application over one day of sun exposure |
| Actinica, 2 mg/cm2, 2 applications | Experimental | Device: Actinica, 2 mg/cm2, 2 applicationsActinica, 2 mg/cm2, 1 application over one day of sun exposure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, 18-60 years of age,
- Subject with Phototype I, II or III,
- Subject with individual typology angle (ITA) 28-70°,
- Subject with healthy skin / not tanned on the back,
Key exclusion criteria (2 listed)
- 1. Subject with obvious skin cancer forms within the test areas, 2. Subject with hairs on the treated area that might interfere with clinical investigation assessments, 3. Subjects who have performed sun bathing at least four months before enrolment, 10. History of sun allergy / Mallorca acne, active photo induced or photo aggravated disease, or abnormal response to the sun (e.g., photosensitive dermatoses, polymorphic light eruption, solar urticaria, systemic lupus erythematosus, or dermatomyositis).
- 11. The subject has received, applied or taken the forbidden treatments within the specified time frame prior to the Day 0 visit (list available on request)
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 |
|---|---|---|
| Actinica, 0.8 mg/cm2, 1 application | Device | Actinica, 0.8 mg/cm2, 1application |
| Actinica, 0.8 mg/cm2, 2 applications | Device | Actinica, 0.8 mg/cm2, 2 applications |
| Actinica, 2 mg/cm2, 1 application | Device | Actinica, 2 mg/cm2, 1 application |
| Actinica, 2 mg/cm2, 2 applications | Device | Actinica, 2 mg/cm2, 2 applications |
Primary outcome
erythema score
Time frame: Part 2 -Day 1
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 18 Feb 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actinica, 0.8 mg/cm2, 1 application, Actinica, 0.8 mg/cm2, 2 applications and Actinica, 2 mg/cm2, 1 application in people with Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin, run by Galderma R&D at 1 site in France.
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 4 inclusion and 2 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 18 Feb 2021. 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 France. 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?
erythema score (time frame: Part 2 -Day 1). 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 18 Feb 2021.