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Brightening Cream and Lasers in Post-sclerotherapy Hyperpigmentation

I

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Varicosis
Hyperpigmentation

Treatments

Device: QS Nd:YAG laser
Drug: Triple cream

Study type

Interventional

Funder types

Other

Identifiers

NCT05165524
2021-D0062

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 3 patient groups

Laser
Active Comparator group
Treatment:
Device: QS Nd:YAG laser
Cream
Active Comparator group
Treatment:
Drug: Triple cream
Control
No Intervention group

Trial contacts and locations

1

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Central trial contact

Kristine Heidemeyer, MD

Data sourced from clinicaltrials.gov

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