Solar LentiginesNCT02153697
Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream
A study testing Q-switched SINON Ruby Laser and Pigmanorm Cream in people with Solar Lentigines, run by University of Zurich at 1 site in Switzerland.
Trial summary
Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals. Their removal may be requested for aesthetic reasons. The goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Solar Lentigines
- What is being tested?
- Q-switched SINON Ruby Laser and Pigmanorm Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Oct 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50
- female patient must be in post-menopause (> 2 years)
- Clinically and dermoscopic confirmed solar lentigines on both sides back of the hands
Who cannot join
- non melanocytic pigmentation, vitiligo, melanoma and suspicion of melanoma
- intolerance against an ingredience of pigmanorm® cream
- acute inflammation or eczema on back of the hands
- patients with renal disease
- intake of photosensibilisating medication in the past 3 months
- treatment of solar lentigines on back of the hands in the past 6 months
- solarium or sun exposure about 6 weeks before and after treatment
- immunsuppressed patients
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Dermatology
Zurich
About this study
Official title: Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream
Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals. Their removal may be requested for aesthetic reasons.
The goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines.
The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser, the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm® cream).
The investigators estimate that a physical therapy with a Q-switched Rubin laser system is more effective in the removal of solar lentigines than a topical chemical therapy with a hydrochinon containing bleaching cream.
- Conditions
- Solar Lentigines
- Being tested
- Q-switched SINON Ruby Laser, Pigmanorm Cream
- Keywords
- solar lentigines, Q-switches Laser, bleaching cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-switched SINON Ruby LaserDevice
Solar lentigines on the right back of the hand side are treated with the Q-switched SINON Ruby Laser at Baseline and if required at day 28.
Pigmanorm CreamDrug
Solar lentigines on the left back of the hand side are treated once a day during 7 weeks with Pigmanorm cream, a bleaching cream containing hydrochinon.
| Study group | Role | What they receive |
|---|---|---|
| Pigmanorm Cream, Q-switched Ruby laser,solar lentigines | Experimental | Solar lentigines on the left back of the hand side are treated with Pigmanorm Cream once a day for 7 weeks. Solar lentigines on the right back of the hand side are treated with a Q-switched Ruby laser at Baseline and if required at day 28. Receives: Device: Q-switched SINON Ruby Laser; Drug: Pigmanorm Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clearing of pigmentation
The primary efficacy objective is to evaluate the clearing of pigmentation(percentage of clearing) following a quartile scale of poor (25% clearance), fair (26-50% clearance), good (51-75% clearance), and excellent (76-100% clearance).
Measured: 140 days (Baseline, Day 28, Day 56, Day 140)
Secondary outcomes (2)
Evaluation of safety profile
Adverse effects are noted at each visit.
Measured: 140 days (Baseline, Day 28, Day 56, Day 140)
Change from Baseline in Pigmentation at day 140
The clearing of pigmentation (percentage of clearing) following a quartile scale of poor (25% clearance), fair (26-50% clearance), good (51-75% clearance), and excellent (76-100% clearance) is assessed at day 140 from Baseline ( = 3 months after finishing treatment).
Measured: Long term outcome is assessed 3 months after finishing treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar LentiginesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153697
- Sponsor's protocol ID
- KEK-ZH-Nr. 2013-0435
- Status last verified
- Dec 2014
- First submitted
- 20 May 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream
- ClinicalTrials.gov ID
- NCT02153697
- Acronym / sponsor ID
- KEK-ZH-Nr. 2013-0435
- Conditions
- Solar Lentigines
- Keywords
- solar lentigines, Q-switches Laser, bleaching cream
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Jun 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.
Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals. Their removal may be requested for aesthetic reasons.
The goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines.
The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser, the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm® cream).
The investigators estimate that a physical therapy with a Q-switched Rubin laser system is more effective in the removal of solar lentigines than a topical chemical therapy with a hydrochinon containing bleaching cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pigmanorm Cream, Q-switched Ruby laser,solar lentigines | Experimental | Device: Q-switched SINON Ruby Laser, Drug: Pigmanorm CreamSolar lentigines on the left back of the hand side are treated with Pigmanorm Cream once a day for 7 weeks. Solar lentigines on the right back of the hand side are treated with a Q-switched Ruby laser at Baseline and if required at day 28. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 50
- female patient must be in post-menopause (> 2 years)
- Clinically and dermoscopic confirmed solar lentigines on both sides back of the hands
Key exclusion criteria (8 listed)
- non melanocytic pigmentation, vitiligo, melanoma and suspicion of melanoma
- intolerance against an ingredience of pigmanorm® cream
- acute inflammation or eczema on back of the hands
- patients with renal disease
- intake of photosensibilisating medication in the past 3 months
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 |
|---|---|---|
| Q-switched SINON Ruby LaserSolar lentigines on the right back of the hand side are treated with the Q-switched SINON Ruby Laser at Baseline and if required at day 28. | Device | Pigmanorm Cream, Q-switched Ruby laser,solar lentigines |
| Pigmanorm CreamSolar lentigines on the left back of the hand side are treated once a day during 7 weeks with Pigmanorm cream, a bleaching cream containing hydrochinon. | Drug | Pigmanorm Cream, Q-switched Ruby laser,solar lentigines |
Primary outcome
Evaluation of clearing of pigmentation
Time frame: 140 days (Baseline, Day 28, Day 56, Day 140)
The primary efficacy objective is to evaluate the clearing of pigmentation(percentage of clearing) following a quartile scale of poor (25% clearance), fair (26-50% clearance), good (51-75% clearance), and excellent (76-100% clearance).
2 secondary outcomes
Evaluation of safety profile
Time frame: 140 days (Baseline, Day 28, Day 56, Day 140)
Change from Baseline in Pigmentation at day 140
Time frame: Long term outcome is assessed 3 months after finishing treatment.
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 16 Dec 2014.
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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.
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 Q-switched SINON Ruby Laser and Pigmanorm Cream in people with Solar Lentigines, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 8 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 16 Dec 2014. 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 Switzerland. 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 clearing of pigmentation (time frame: 140 days (Baseline, Day 28, Day 56, Day 140)). 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 16 Dec 2014.