Solar LentiginesNCT01778179
A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy
A study testing Tri-luma and Cryotherapy (CRY-AC3® device) in people with Solar Lentigines, run by Hexsel Dermatology Clinic.
Trial summary
To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Solar Lentigines
- What is being tested?
- Tri-luma and Cryotherapy (CRY-AC3® device)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
- Female and male subjects;
- Phototype II to IV;
- Subjects aged between 40 and 65 years;
- Subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter
- History of post-inflammatory hyperpigmentation on body or face
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- Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation;
- Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study;
- Availability of the subject throughout the study;
- Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study;
- Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.
Who cannot join
- Pregnant women or women intending to become pregnant in the following 5 months after screening;
- Lactation period;
- Subjects participating in other clinical trials;
- Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
- Subjects with neoplastic, muscular or neurological diseases;
- Subjects with inflammation or active infection in the area to be studied;
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- Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula,
- Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol;
- Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
About this study
Official title: Safety and Efficacy of a Triple Combination Cream as Adjuvant Treatment of Solar Lentigines With Cryotherapy.
To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
Read the detailed description
To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5, 9 and 13 after the cryotherapy.
- Conditions
- Solar Lentigines
- Being tested
- Tri-luma, Cryotherapy (CRY-AC3® device)
- Keywords
- Lentigines, Cryotherapy, hyperpigmentation
- Medical subject headings
- Lentigo, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-lumaDrug
Pre-procedure phase (From Baseline up to Week 2) treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks.
Post-procedure phase (From week 2 up to Week 13 - Visit )
- Tri-Luma® cream treatment phase (from week 5 up to week 13 - visit 3 up to visit 5):The investigational drug (Tri-Luma® cream) will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.
Cryotherapy (CRY-AC3® device)Procedure or surgery
Procedure performed at week 2.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Subjects (group 1) will be treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects will have the solar lentigines treated by cryotherapy (CRY-AC3® device).
Post-procedure phase (From Week 2 up to Week 13)
* Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5):
The investigational drug (Tri-Luma® cream) plus sunscreen will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. Receives: Drug: Tri-luma; Procedure: Cryotherapy (CRY-AC3® device) |
| Group 2 | Placebo comparator | Subjects (group 2) will be treated daily for their solar lentigines with sunscreen alone for 2 weeks. At week 2, all the subjects will have the solar lentigines will treated by cryotherapy (CRY-AC3® device).
Post-procedure phase (Week 2 up to Week 13)
* Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5):
Sunscreen alone will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. Receives: Procedure: Cryotherapy (CRY-AC3® device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solar Lentigines Count
Solar lentigines count up to 13 weeks
Measured: up to 13 weeks
Secondary outcomes (1)
Change From Baseline in Melanin Levels
This assessment was made using a narrowband reflectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments.
The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin.
Measured: Baseline and up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solar LentiginesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doris Hexsel, Hexsel Dermatology Clinic
- Investigators
- Doris Hexsel, MD, Principal investigator, Brazilian Center for Studies in Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778179
- Sponsor's protocol ID
- 2012-03
- Status last verified
- Sep 2020
- First submitted
- 4 Jan 2013
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Triple Combination Cream as Adjuvant Treatment of Solar Lentigines With Cryotherapy.
- ClinicalTrials.gov ID
- NCT01778179
- Acronym / sponsor ID
- 2012-03
- Conditions
- Solar Lentigines
- Keywords
- Lentigines, Cryotherapy, hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Posted 17 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
Detailed description
To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5, 9 and 13 after the cryotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Tri-luma, Procedure: Cryotherapy (CRY-AC3® device)Subjects (group 1) will be treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects will have the solar lentigines treated by cryotherapy (CRY-AC3® device). Post-procedure phase (From Week 2 up to Week 13) * Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks. * Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5): The investigational drug (Tri-Luma® cream) plus sunscreen will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. |
| Group 2 | Placebo comparator | Procedure: Cryotherapy (CRY-AC3® device)Subjects (group 2) will be treated daily for their solar lentigines with sunscreen alone for 2 weeks. At week 2, all the subjects will have the solar lentigines will treated by cryotherapy (CRY-AC3® device). Post-procedure phase (Week 2 up to Week 13) * Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks. * Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5): Sunscreen alone will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
- Female and male subjects;
- Phototype II to IV;
- Subjects aged between 40 and 65 years;
- Subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter
Key exclusion criteria (9 listed)
- Pregnant women or women intending to become pregnant in the following 5 months after screening;
- Lactation period;
- Subjects participating in other clinical trials;
- Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
- Subjects with neoplastic, muscular or neurological diseases;
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 |
|---|---|---|
| Tri-lumaPre-procedure phase (From Baseline up to Week 2) treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks. Post-procedure phase (From week 2 up to Week 13 - Visit ) - Tri-Luma® cream treatment phase (from week 5 up to week 13 - visit 3 up to visit 5):The investigational drug (Tri-Luma® cream) will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH. | Drug | Group 1 |
| Cryotherapy (CRY-AC3® device)Procedure performed at week 2. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Solar Lentigines Count
Time frame: up to 13 weeks
Solar lentigines count up to 13 weeks
1 secondary outcome
Change From Baseline in Melanin Levels
Time frame: Baseline and up to 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Doris Hexsel, MD principal investigator
Brazilian Center for Studies in Dermatology
Questions about this trial
What is this clinical trial studying?
A study testing Tri-luma and Cryotherapy (CRY-AC3® device) in people with Solar Lentigines, run by Hexsel Dermatology Clinic.
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 9 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Solar Lentigines Count (time frame: up to 13 weeks). 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 14 Oct 2020.