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

Solar Lentigines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153697
• Other study ID #: KEK-ZH-Nr. 2013-0435
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: December 15, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lentigo
• Solar Lentigines

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Dermatology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	140 days (Baseline, Day 28, Day 56, Day 140)	No
Secondary	Evaluation of safety profile	Adverse effects are noted at each visit.	140 days (Baseline, Day 28, Day 56, Day 140)	Yes
Secondary	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).	Long term outcome is assessed 3 months after finishing treatment.	No