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

NCT02153697 | Completed DMC

• 1 other identifier: KEK-ZH-Nr. 2013-0435
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Solar Lentigines

Keywords

solar lentigines; Q-switches Laser; bleaching cream

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Evaluation of safety profile

  140 days (Baseline, Day 28, Day 56, Day 140)

• Change from Baseline in Pigmentation at day 140

  Long term outcome is assessed 3 months after finishing treatment.

Study Arms (1)

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.

Device: Q-switched SINON Ruby Laser; Drug: Pigmanorm Cream

Interventions

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, Q-switched Ruby laser,solar lentigines

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.

Pigmanorm Cream, Q-switched Ruby laser,solar lentigines

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Dermatology

Zurich, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: June 3, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

CH (1)