Brightening Cream and Lasers in Post-sclerotherapy Hyperpigmentation

Hyperpigmentation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165524
• Other study ID #: 2021-D0062
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Kristine Heidemeyer, MD
• Phone: 316322218
• Email: Kristine.Heidemeyer[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperpigmentation
• Varicosis

Intervention

Device:
• QS Nd:YAG laser
Patients will be treated with Quality-switched (QS) Neodymium-doped yttrium aluminum garnet (Nd:YAG) laser (MedLite® C6) operating at a wavelength of 1064 nm, fluence range from 2.1 J/cm2 to 8.1 J/cm2 with a 4-6mm spot size.

Drug:
• Triple cream
Patients will be treated with a triple brightening cream (Pigmanorm®), applied daily, three times per week for 12 weeks on the lesion. Interruption for 4 days will be adopted in case of irritation/redness. 50+ sun protection cream will be used as well during the treatment period.

Locations

Country	Name	City	State
Switzerland	Department of dermatology, University Hospital Inselspital, Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalence of laser and cream in reducing post-sclerotherapy hyperpigmentation as assessed by SHI	Equivalence of laser and cream groups in reducing post-sclerotherapy hyperpigmentation as assessed by Skin Hyperpigmentation Index (SHI), ranging from 1 to 4, with higher score indicating a worst hyperpigmentation.	16 weeks
Secondary	Efficacy of laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group as assessed by SHI	Any reduction of post-sclerotherapy hyperpigmentation in laser and cream compared to control group as assessed by Skin Hyperpigmentation Index (SHI), ranging from 1 to 4, with higher score indicating a worst hyperpigmentation.	4, 8, 12, 16 weeks
Secondary	Efficacy of laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group as assessed by PGA	Any reduction of post-sclerotherapy hyperpigmentation in laser and cream compared to control group as assessed by 6-point Physician Global Assessment (PGA), based on before-after pictures of lesions assessment, ranging from 1 to 6, with higher scores indicating a better outcome.	4, 8, 12, 16 weeks
Secondary	Patient's satisfaction related to laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group	Any difference of patient's satisfaction between laser and cream compared to control group as assessed by a 9-point anchored visual analogue scale (VAS), ranging from -4 to +4, with negative scores indicating a worsening of condition, with 0 indicating no difference and with positive scores indicating an improvement.	16 weeks