Skip to main content
OpenTrials
Completed

NCT Number: NCT02153697

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solar Lentigines

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Division of Dermatology

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Q-switched SINON Ruby Laser

Device

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 Cream

Drug

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2014
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.