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Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream

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ClinicalTrials.gov Identifier: NCT02153697
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Solar Lentigines Device: Q-switched SINON Ruby Laser Drug: Pigmanorm Cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Pigmanorm Cream, Q-switched Ruby laser,solar lentigines
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.
Device: Q-switched SINON Ruby Laser
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.

Drug: Pigmanorm Cream
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Evaluation of safety profile [ Time Frame: 140 days (Baseline, Day 28, Day 56, Day 140) ]
    Adverse effects are noted at each visit.

  2. Change from Baseline in Pigmentation at day 140 [ Time Frame: Long term outcome is assessed 3 months after finishing treatment. ]
    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).



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 50
  • female patient must be in post-menopause (> 2 years)
  • Clinically and dermoscopic confirmed solar lentigines on both sides back of the hands

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153697


Locations
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Switzerland
University Hospital Zurich, Division of Dermatology
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02153697     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2013-0435
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Keywords provided by University of Zurich:
solar lentigines
Q-switches Laser
bleaching cream
Additional relevant MeSH terms:
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Lentigo
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases