Rosacea is a frequent chronic inflammatory disease affecting mainly the face but also eyes and scalp. Rosacea is classified into 3 types: erythemato-teleangiectatica, papulopustulosa and phymatosa. Treatments depend on the type and include topical and systemic antibiotics, azelaic acid, topical ivermectin, topical brimonidine, systemic isotretinoin as well as intense pulsed light (IPL) and laser therapies. For treatment of telangiectasia and redness, laser and IPL therapies are the first choice. Vascular lasers, such as pulsed dye lasers (PDL) and potassium-titanyl phosphate (KTP) lasers as well as IPL, have demonstrated good efficacy in reduction of erythema and telangiectasias in patients with rosacea. However, these treatments are expensive and mostly not covered by the health insurance. Therefore, for patients it is important to receive the maximal effect and improvement after each single laser session. Ivermectin is a semi-synthetic derivative of avermectin and has an anti-inflammatory effect as well as an antiparasitic effect on demodex mite. The latter is playing an important pathogenetic role in rosacea. This randomized controlled study aims to compare the effect of KTP laser in combination with ivermectin 1% cream vs KTP laser alone in patients with facial rosacea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
Treatment with KTP 532 nm laser. Laser fluence depends on erythema intensity and ranges from 7.0 J/cm2 to 11 J/cm2 with a 4-11 mm spot size and 8-12 ms pulse duration.
Application of ivermectin 1% cream 1x/day. Interruption for 4 days in case of irritation/redness.
Department of dermatology, University Hospital Inselspital, Bern
Bern, Switzerland
Efficacy of laser and cream vs laser alone in reducing erythema as assessed by NEI
Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Normalized Erythema Index (NEI), ranging from 0 to 80, with higher values indicating a worst erythema.
Time frame: 16 weeks
Efficacy of laser and cream vs laser alone in reducing erythema as assessed by SRI
Any relative decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Skin Redness Index (SRI), ranging from 1 to 4, with higher score indicating a worst erythema.
Time frame: 16 weeks
Efficacy of laser and cream vs laser alone in reducing erythema as assessed by CEA
Any decrease of erythema on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by Clinical Erythema Assessment (CEA), ranging from 0 to 4, with higher score indicating a worst erythema.
Time frame: 4, 8, 12, 16 weeks
Efficacy of laser and cream vs laser alone in the clinical improvement of skin lesions as assessed by PGA
Any change of skin lesions on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by 6-point Physician Global Assessment (PGA), ranging from 0 to 5, with higher score indicating a better outcome.
Time frame: 4, 8, 12, 16 weeks
Patient's satisfaction related to laser and cream vs laser alone in the improvement of skin lesions as assessed by VAS
Any difference of patient's satisfaction for the improvement of skin lesions on the side treated with KTP laser and ivermectin 1% cream vs laser alone 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.
Time frame: 4, 8, 12, 16 weeks
Efficacy of laser and cream vs laser alone in reducing telangiectasia severity as assessed by TGS
Any change of telangiectasia severity on the side treated with KTP laser and ivermectin 1% cream vs laser alone as assessed by telangiectasia grading scale (TGS), ranging from 0 to 3, with higher score indicating a worst telangiectasia severity.
Time frame: 4, 8, 12, 16 weeks
Efficacy of laser and cream vs laser alone in reducing papules and papulopustules
Any change in the number of papules and papulopustules on the side treated with KTP laser and ivermectin 1% cream vs laser alone.
Time frame: 4, 8, 12, 16 weeks
Efficacy of laser and cream vs laser alone in reducing face swelling as assessed by the patient
Any change in the number of days of face swelling on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient
Time frame: 4, 8, 12, 16 weeks
Efficacy of laser and cream vs laser alone in reducing face redness as assessed by the patient
Any change in the number of days of face redness on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient.
Time frame: 4, 8, 12, 16 weeks
Efficacy of laser and cream vs laser alone in reducing face purpura as assessed by the patient
Any change in the number of days of face purpura on the side treated with KTP laser and ivermectin 1% cream vs laser alone, as assessed by the patient.
Time frame: 4, 8, 12, 16 weeks
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