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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02153697

Enrollment

Registered

2014-06-03

Start date

2014-03-31

Completion date

2014-10-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solar Lentigines

Keywords

solar lentigines, Q-switches Laser, bleaching cream

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.

Interventions

DEVICEQ-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.

DRUGPigmanorm 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of clearing of pigmentation	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

Measure	Time frame	Description
Evaluation of safety profile	140 days (Baseline, Day 28, Day 56, Day 140)	Adverse effects are noted at each visit.
Change from Baseline in Pigmentation at day 140	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).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026