Clinical trial NCT05165524: Brightening Cream and Lasers in Post-sclerotherapy Hyperpigmentation
Official title: Comparison of the Effectiveness of Brightening Creams vs Laser Therapy (QS Nd:YAG 1064nm Laser) in Skin Hyperpigmentation After Sclerotherapy by Objective Measurement: A Randomized Controlled Monocentric Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperpigmentation
Varicosis
Keywords: laser
Nd:YAG
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of leg veins and varicosis with sclerotherapy is one of the most frequently performed medical intervention in the western world. The most common local side effects of this treatment are hyperpigmentations caused by hemosiderin deposition in the skin as well as post inflammatory hyperpigmentation.

Although skin hyperpigmentation after sclerotherapy is a common over several months up to years lasting side-effect with a strong aesthetic impact, scanty data exist about treatment options.

Quality-Switched (QS) lasers are efficient in the removal of exogenous and endogenous pigments, such as tattoos as well as epidermal and dermal melanin deposits. The laser light is absorbed by pigment particles, leading to a fragmentation of these particles by a photothermal and photoacoustic effect. Smaller particles can be then phagocyted by macrophages, and transported via the lymphatic system into the lymph nodes. Furthermore, the positive effect of QS lasers in the management of cutaneous siderosis in stasis dermatitis and after sclerotherapy has been described in several cases.

Triple cream including hydroquinone, tretinoin and a topical corticosteroid (eg dexamethasone), is the first line therapy in the treatment of post inflammatory hyperpigmentation.

This randomized controlled study aims to evaluate the efficiency of two well-known depigmentation methods (QS laser and triple cream) for treatment of post sclerotherapy hyperpigmentation, compared with a control group performing no treatment.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick skin type I-IV
* Presence of at least 1 postinflammatory hyperpigmentation after sclerotherapy

Exclusion Criteria:

* History of adverse events related to short-pulsed laser therapy
* Pregnant or breast-feeding women
* Intention to become pregnant during the course of the study
* History of intolerance or allergic reaction to triple cream or one of its ingredients
* Prior treatment with parenteral gold therapy
* Inability to understand the study content

Primary outcomes:
measure: Equivalence of laser and cream in reducing post-sclerotherapy hyperpigmentation as assessed by SHI
timeFrame: 16 weeks
Secondary outcomes:
measure: Efficacy of laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group as assessed by SHI
timeFrame: 4, 8, 12, 16 weeks
measure: Efficacy of laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group as assessed by PGA
timeFrame: 4, 8, 12, 16 weeks
measure: Patient's satisfaction related to laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of dermatology, University Hospital Inselspital, Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Kristine Heidemeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: