IMPORTANT SAFETY INFORMATION

PRESCRIBING INFORMATION

Time To Relapse

 

Not an actual patient
 

More time 'clear'

SOOLANTRA® (ivermectin) Cream, 1% gives patients more time ‘clear’ (IGA 0) from the inflammatory lesions of rosacea1

Better results with SOOLANTRA Cream vs METROCREAM Topical Cream, 0.75% confirmed in the first and only large-scale rosacea relapse study.1

The efficacy and safety of SOOLANTRA Cream QD and METROCREAM Topical Cream, 0.75% BID was evaluated in subjects with inflamatory lesions of rosacea over a 16-week treatment period, continuing to the 36-week extension evaluating relapse after a treament-free period.1,2

Tube of Soolantra cream.

Offering relief to your patients for longer

At the end of the 36-week extension study:

In a head to head trial with MetroCream Topical Cream, nearly 1 out of 3 Soolantra patients remained clear or almost clear at 1 year and 33% more subjects had no rosacea relapse with Soolantra vs. MetroCream.

patients were still ‘clear’ (IGA 0) or ‘almost clear’ (IGA 1) at year 1 with SOOLANTRA Cream vs METROCREAM Topical cream, 0.75% (32% vs 24%), observed every 4 weeks from Week 16 to Week 521†

†Clear defined as IGA 0 according to IGA scale (Investigator Global Assessment), which is commonly used by dermatologists IGA=Investigator’s Global Assessment.

36-week extension study to assess subjects after 16 weeks of successful treatment (IGA score of 0 or 1)1

More subjects were rated clear or almost clear and maintained that success post-treatment with SOOLANTRA Cream, 1% vs METROCREAM Topical Cream, 0.75%

Photos of study subject's progress at weeks 16, 32, and 52 from baseline. IGA Score at baseline 3/moderate, week 16 1/almost clear, week 32 2/mild, and week 52 1/almost clear.Photos of study subject's progress at weeks 16, 32, and 52 from baseline. IGA Score at baseline 3/moderate, week 16 0/clear, week 32 0/clear, and week 52 1/almost clear.
 

Low incidence of adverse events vs METROCREAM Topical Cream, 0.75%3

TREATMENT-RELATED ADVERSE EVENTS (AEs)

 

  SOOLANTRA Cream,
1% ONCE DAILY (n=478)		 METROCREAM Topical Creambr /> 0.75% TWICE DAILY (n=484)
TOTAL NUMBER OF RELATED AEs, n 13 25
TOTAL NUMBER OF SUBJECTS WITH RELATED AEs, n(%) 11 (2.3) 18 (3.7)
SKIN IRRITATION 3 (0.6) 4 (0.8)
ERYTHEMA 2 (0.4) 1 (0.2)
ROSACEA 2 (0.4) 3 (0.6)
PRURITUS 1 (0.2) 2 (0.4)
DERMATITIS ALLERGIC - 2 (0.4)

Significantly longer time to first relapse1

Image showing patients using Soolantra had 115 days to first relapse vs. MetroCream with 85 days to first relapse.

Study Design

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA Cream once daily with METROCREAM Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (Investigator’s Global Assessment [IGA] score of 3 or 4) over a 16-week treatment period (Part A). A total of 757 successfully treated subjects, rated clear or almost clear (IGA score of 0 or 1), continued to the 36-week extension evaluating relapse after a treatment-free period (Part B).1,2

In Part B, subjects were followed every 4 weeks for up to 36 additional weeks (Weeks 16-52). If relapse (defined as IGA score of ≥2 [mild, moderate, or severe]) occurred, subjects were re-treated with the same treatment they had received during the initial 16-week study (Part A). Re-treatment was stopped when subject(s) achieved an IGA of ≤1 (clear or almost clear), with a maximum duration of re-treatment of 16 consecutive weeks to mimic the Part A treatment duration. Several re-treatment periods were permitted.1

Two weeks in and I have already started to see a noticable improvement with my rosacea bumps and blemishes*

Woman with rosacea.

Not an actual patient

*Individual results may vary

Important Safety Information

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Not for oral, ophthalmic or intravaginal use. Adverse Events: In clinical trials with SOOLANTRA Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit WWW.FDA.GOV/MEDWATCH or call 1-800-FDA-1088.


References 1. Taieb A, et al. Maintenance of remission following successful treatment of papulopustular rosacea with ivermectin 1% cream vs. metronidazole 0.75% cream: 36-week extension of the ATTRACT randomized study. J Eur Acad Dermatol Venereol. 2015;829–836. 2. Taieb A, Ortonne JP, Ruzicka T, et al; lvermectin Phase III Study Group. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized, investigator-blinded trial. Br J Dermatol. 2015;172(4):1103-1110. 3. Data on file. Galderma Laboratories, L.P.

See Important Safety Information

IMPORTANT SAFETY INFORMATION

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Adverse Events: In clinical trials with SOOLANTRA® Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation.
Warnings / Precautions: Not for oral, ophthalmic or intravaginal use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit WWW.FDA.GOV/MEDWATCH or call 1-800-FDA-1088.

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