HealthyNCT01448122
Avene Compact Honey for Prevention of Pigmentation From Visible Light
A study testing Avene Compact Honey SPF 50 in people with Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in Canada.
Trial summary
The main objective of the study is to assess the efficacy of Avène Compact Honey in preventing pigmentation induced by visible light in subjects with a phototype III or IV. Patients will be exposed to a range of visible light to areas on the back to confirm study eligibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Avene Compact Honey SPF 50
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or female, 18 years of age or older at time of consent.
- Subject has a skin phototype of III or IV.
- Subject (or subject's partner), male or female, is willing to use effective contraceptive method for at least 30 days before Day -7 and until Day 7. Effective contraceptive methods are:
- Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
- Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
- Intrauterine device (IUD);
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- Sterilization such as tubal ligation, hysterectomy or vasectomy;
- Postmenopausal state for at least 1 year for female subject or female partner of male subject;
- Same-sex partner;
- Abstinence.
- Subject must be willing to avoid exposure to UV radiation (tanning beds, phototherapy, and sunlight) on the back for the duration of the study.
- Subject is capable of giving informed consent and the consent must be obtained prior to any study related procedures.
- Subject has sufficient pigmentation at Day 0 in at least one area after exposure to varying doses of visible light at Day -7.
Who cannot join
- Subject is currently pregnant or lactating.
- Subject has a known allergy to the study product or a component of the study product.
- Subject has used photosensitizing medication (in UV and in the visible range) within 30 days of the Day -7 visit up to the Day 7 visit.
- Subject has a history of photodermatosis.
- Subject has the presence of a skin disorder in the area to be irradiated that would either put the subject at increased risk or interfere with pigmentation evaluation.
- Subject has a medical condition or is taking medication that could put him or her at undue risk.
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- Subject has a cardiovascular, pulmonary, digestive, neurological, urinary, psychiatric, hematological, immunological, or endocrinal pathology that is unstable or able to interfere with the study.
- Subject has undergone organ removal or organ transplant
- Subject is currently receiving treatment that may interfere with interpretation of the study results.
- Subject for whom, in the Investigator's opinion, pigmentation on the back will be difficult to evaluate (such as subjects with excessive hair or a tattoo).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-blind Study of the Ability of Avène Compact Honey to Prevent Pigmentation Induced by Visible Light in Subjects With Skin Phototype III or IV
The main objective of the study is to assess the efficacy of Avène Compact Honey in preventing pigmentation induced by visible light in subjects with a phototype III or IV.
Patients will be exposed to a range of visible light to areas on the back to confirm study eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible to continue.
Read more
Eligible patients will have study product applied to part of the back. The back will be exposed to a range of light based on the minimum exposure inducing pigmentation previously ascertained. The area where study product is applied will have a higher range of light exposure than the area without the study product.
Seven days later, the areas will be examined to determine the lowest exposure inducing pigmentation on the sides with and without study product. The color will also be measured between two identical exposures with and without the applied study product.
Read the detailed description
Part A At Day -7, all subjects will be exposed to a range of doses of visible light on an approximately 0.90 cm diameter area on the back to ascertain their predisposition for pigmentation induced by visible light. The doses will be 30, 40, 60, 80, 100 and 120 J cm-2. At the Day 0 visit, subjects' pigmentation will be determined by investigator visual assessment. Subjects with a lowest observed pigmentation at the 30 J cm-2 or the 120 J cm-2 dose will not continue in the study. For each subject that continues, the area where Avène Compact Honey will be applied on the back will be randomized. At least 15 minutes later, unprotected areas will be exposed to doses ranging from ~1/20th to 1.8 times the lowest dose of visible light that induced pigmentation at Day -7. To not unnecessarily over expose subjects, the first 3 will have protected areas exposed to doses ranging from ~half to 16 times the lowest dose of visible light that induced pigmentation at Day -7. All subjects will have an additional exposure on the protected side equal to the highest dose of the unprotected side for colorimetric comparison. Subjects will be examined at Day 7 (seven days after visible light exposure). Pigmentation on all exposed areas will be evaluated by investigator visual assessment. The colorimetric measurements on protected and unprotected skin will be recorded for the equivalent exposures and for adjacent skin. The exposed area on the protected side to be tested with colorimetric analysis will be hidden during the investigator visual assessment. The minimum dose on the unprotected side and an area of unprotected and unexposed skin will be hidden from the colorimetric evaluator to maintain the blind. The lowest visible light dose inducing pigmentation will be recorded for both the unprotected and protected areas. If the first three subjects are only pigmented at either the 16X level or not at all on the protected side, then the remaining subjects in the study will be exposed at doses ranging from 0.7 to as high as 24 times the lowest dose of visible light that induced pigmentation at Day -7.
Part B At Day 0, all subjects will be exposed to a range of doses of visible light on an approximately 0.90 cm diameter area on the back to ascertain their disposition for pigmentation induced by visible light. The doses will be 8, 40, 80, 160, 320 and 480 J cm-2. At the Day 7 visit, subjects' pigmentation will be determined by investigator visual assessment. Subjects will be divided into 2 cohorts. Cohort A will contain 5 subjects of phototype IV with dark skin and cohort B will contain 5 subjects with skin phototype V.
Part C At Day -7, all subjects will be exposed to a range of doses of visible light on an approximately 0.90 cm diameter area on the back to ascertain their predisposition for pigmentation induced by visible light. The doses will be 8, 40, 80, 160, 320 and 480 J cm-2. At the Day 0 visit, subjects' pigmentation will be determined by investigator visual assessment. Subjects with a lowest observed pigmentation at the 8 J cm-2 dose will not continue in the study and neither will subjects showing no pigmentation at 480 J cm-2. For each subject that continues, the area where Avène Compact Honey will be applied on the back will be randomized and then receive the application. At least 15 minutes later, protected areas will be exposed to doses of 32, 160, 320, 640, 1280 and 1920 cm-2. Unprotected areas will be exposed to the same doses as Day 0. To not unnecessarily over expose subjects, those with a lowest observed pigmentation at Day 0 of 40 or 80 J cm-2 will have the maximum exposure at Day 0 determined at the investigators discretion. Subjects will be examined at Day 7 (seven days after visible light exposure). Pigmentation on all exposed areas will be evaluated by investigator visual assessment. The lowest visible light dose inducing pigmentation will be recorded for both the unprotected and protected areas. The colorimetric measurements on protected and unprotected skin will be recorded for the equivalent exposures and for adjacent skin. Four areas of unprotected and protected skin will be hidden from the colorimetric evaluator to maintain the blind. Subjects will be divided into 2 cohorts. Cohort A will contain 5 subjects of phototype IV with dark skin and cohort B will contain 5 subjects with skin phototype V.
- Conditions
- Healthy
- Being tested
- Avene Compact Honey SPF 50
- Keywords
- Prevention of pigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avene Compact Honey SPF 50Other
Also called Avene Compact Doré SPF 50
Patients will have part of their back covered with 2 mg/mL of Avene Compact Honey SPF 50.
| Study group | Role | What they receive |
|---|---|---|
| Avene Compact Honey SPF 50 | Active comparator | Study product will be scraped from compact case and weighed. Product will be applied to half the area to be exposed with visible light at a concentration of 2 mg/mL. Receives: Other: Avene Compact Honey SPF 50 |
| No intervention | No intervention | Half of the area to be exposed to visible light will have no study product applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest mean fluence inducing visible pigmentation
Lowest mean fluence inducing visible pigmentation 7 days after visible light exposure for skin protected with Avène Compact Honey as compared to unprotected skin.
Measured: 7 days
Secondary outcomes (2)
Mean difference in pigmentation darkness
Mean difference in pigmentation (as evaluated by the L* component of colorimetric measurements) between exposed and non exposed skin according to fluence for skin protected with Avène Compact Honey as compared to unprotected skin.
Measured: 7 Days
Adverse Events
The safety of Avène Compact Honey measured by the number of adverse events and severity of adverse events.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr Robert Bissonnette, Pierre Fabre Dermo Cosmetique
- Investigators
- Robert Bissonnette, MD, FRCPC, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448122
- Sponsor's protocol ID
- RV 4140 A 2011 176
- Status last verified
- Feb 2013
- First submitted
- 5 Oct 2011
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind Study of the Ability of Avène Compact Honey to Prevent Pigmentation Induced by Visible Light in Subjects With Skin Phototype III or IV
- ClinicalTrials.gov ID
- NCT01448122
- Acronym / sponsor ID
- RV 4140 A 2011 176
- Conditions
- Healthy
- Keywords
- Prevention of pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Oct 2011 (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 main objective of the study is to assess the efficacy of Avène Compact Honey in preventing pigmentation induced by visible light in subjects with a phototype III or IV.
Patients will be exposed to a range of visible light to areas on the back to confirm study eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible to continue.
Eligible patients will have study product applied to part of the back. The back will be exposed to a range of light based on the minimum exposure inducing pigmentation previously ascertained. The area where study product is applied will have a higher range of light exposure than the area without the study product.
Seven days later, the areas will be examined to determine the lowest exposure inducing pigmentation on the sides with and without study product. The color will also be measured between two identical exposures with and without the applied study product.
Detailed description
Part A At Day -7, all subjects will be exposed to a range of doses of visible light on an approximately 0.90 cm diameter area on the back to ascertain their predisposition for pigmentation induced by visible light. The doses will be 30, 40, 60, 80, 100 and 120 J cm-2. At the Day 0 visit, subjects' pigmentation will be determined by investigator visual assessment. Subjects with a lowest observed pigmentation at the 30 J cm-2 or the 120 J cm-2 dose will not continue in the study. For each subject that continues, the area where Avène Compact Honey will be applied on the back will be randomized. At least 15 minutes later, unprotected areas will be exposed to doses ranging from ~1/20th to 1.8 times the lowest dose of visible light that induced pigmentation at Day -7. To not unnecessarily over expose subjects, the first 3 will have protected areas exposed to doses ranging from ~half to 16 times the lowest dose of visible light that induced pigmentation at Day -7. All subjects will have an additional exposure on the protected side equal to the highest dose of the unprotected side for colorimetric comparison. Subjects will be examined at Day 7 (seven days after visible light exposure). Pigmentation on all exposed areas will be evaluated by investigator visual assessment. The colorimetric measurements on protected and unprotected skin will be recorded for the equivalent exposures and for adjacent skin. The exposed area on the protected side to be tested with colorimetric analysis will be hidden during the investigator visual assessment. The minimum dose on the unprotected side and an area of unprotected and unexposed skin will be hidden from the colorimetric evaluator to maintain the blind. The lowest visible light dose inducing pigmentation will be recorded for both the unprotected and protected areas. If the first three subjects are only pigmented at either the 16X level or not at all on the protected side, then the remaining subjects in the study will be exposed at doses ranging from 0.7 to as high as 24 times the lowest dose of visible light that induced pigmentation at Day -7.
Part B At Day 0, all subjects will be exposed to a range of doses of visible light on an approximately 0.90 cm diameter area on the back to ascertain their disposition for pigmentation induced by visible light. The doses will be 8, 40, 80, 160, 320 and 480 J cm-2. At the Day 7 visit, subjects' pigmentation will be determined by investigator visual assessment. Subjects will be divided into 2 cohorts. Cohort A will contain 5 subjects of phototype IV with dark skin and cohort B will contain 5 subjects with skin phototype V.
Part C At Day -7, all subjects will be exposed to a range of doses of visible light on an approximately 0.90 cm diameter area on the back to ascertain their predisposition for pigmentation induced by visible light. The doses will be 8, 40, 80, 160, 320 and 480 J cm-2. At the Day 0 visit, subjects' pigmentation will be determined by investigator visual assessment. Subjects with a lowest observed pigmentation at the 8 J cm-2 dose will not continue in the study and neither will subjects showing no pigmentation at 480 J cm-2. For each subject that continues, the area where Avène Compact Honey will be applied on the back will be randomized and then receive the application. At least 15 minutes later, protected areas will be exposed to doses of 32, 160, 320, 640, 1280 and 1920 cm-2. Unprotected areas will be exposed to the same doses as Day 0. To not unnecessarily over expose subjects, those with a lowest observed pigmentation at Day 0 of 40 or 80 J cm-2 will have the maximum exposure at Day 0 determined at the investigators discretion. Subjects will be examined at Day 7 (seven days after visible light exposure). Pigmentation on all exposed areas will be evaluated by investigator visual assessment. The lowest visible light dose inducing pigmentation will be recorded for both the unprotected and protected areas. The colorimetric measurements on protected and unprotected skin will be recorded for the equivalent exposures and for adjacent skin. Four areas of unprotected and protected skin will be hidden from the colorimetric evaluator to maintain the blind. Subjects will be divided into 2 cohorts. Cohort A will contain 5 subjects of phototype IV with dark skin and cohort B will contain 5 subjects with skin phototype V.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avene Compact Honey SPF 50 | Active comparator | Other: Avene Compact Honey SPF 50Study product will be scraped from compact case and weighed. Product will be applied to half the area to be exposed with visible light at a concentration of 2 mg/mL. |
| No intervention | No intervention | –Half of the area to be exposed to visible light will have no study product applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is male or female, 18 years of age or older at time of consent.
- Subject has a skin phototype of III or IV.
- Subject (or subject's partner), male or female, is willing to use effective contraceptive method for at least 30 days before Day -7 and until Day 7. Effective contraceptive methods are:
- Subject must be willing to avoid exposure to UV radiation (tanning beds, phototherapy, and sunlight) on the back for the duration of the study.
- Subject is capable of giving informed consent and the consent must be obtained prior to any study related procedures.
Key exclusion criteria (10 listed)
- Subject is currently pregnant or lactating.
- Subject has a known allergy to the study product or a component of the study product.
- Subject has used photosensitizing medication (in UV and in the visible range) within 30 days of the Day -7 visit up to the Day 7 visit.
- Subject has a history of photodermatosis.
- Subject has the presence of a skin disorder in the area to be irradiated that would either put the subject at increased risk or interfere with pigmentation evaluation.
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 |
|---|---|---|
| Avene Compact Honey SPF 50Also: Avene Compact Doré SPF 50Patients will have part of their back covered with 2 mg/mL of Avene Compact Honey SPF 50. | Other | Avene Compact Honey SPF 50 |
Primary outcome
Lowest mean fluence inducing visible pigmentation
Time frame: 7 days
Lowest mean fluence inducing visible pigmentation 7 days after visible light exposure for skin protected with Avène Compact Honey as compared to unprotected skin.
2 secondary outcomes
Mean difference in pigmentation darkness
Time frame: 7 Days
Adverse Events
Time frame: 7 Days
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 27 Feb 2013.
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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.
Robert Bissonnette, MD, FRCPC principal investigator
Innovaderm Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avene Compact Honey SPF 50 in people with Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in Canada.
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 13 inclusion and 10 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 27 Feb 2013. 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 Canada. 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?
Lowest mean fluence inducing visible pigmentation (time frame: 7 days). 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 Feb 2013.