IMPORTANT SAFETY INFORMATION

PRESCRIBING INFORMATION

Efficacy

 

Not an actual patient
 

The results are clearer1,2

Powerful inflammatory lesion reductions

Dr. Linda Stein Gold Discusses SOOLANTRA® (ivermectin) Cream, 1% Clinical Data

Dr. Linda Stein Gold is a Galderma consultant and a clinical investigator for the phase 3 efficacy and safety trials of SOOLANTRA Cream in patients with inflammatory lesions of rosacea.

In this video, Dr. Stein Gold reviews the study design and clinical data comparing SOOLANTRA Cream vs vehicle at Week 12, as well as, the 40-week extension safety study comparing SOOLANTRA Cream QD vs azelaic acid 15% gel BID.

A closer look at the IGA scale

Woman with severe IGA 4.Woman with moderate IGA 3.Woman with mild IGA 2.Woman with almost clear IGA 1.Woman with clear IGA o.

SEVERE IGA 4

MODERATE IGA 3

MILD IGA 2

ALMOST CLEAR IGA 1

CLEAR IGA 0

Numerous small and/or large papules/pustules, severe erythema*

Several small or large papules/pustules, moderate erythema*

Few small papules/pustules, mild erythema*

Very few small papule/pustules, very mild erythema present*

No inflammatory lesions present, no erythema*

*All images have been digitally enhanced to demonstrate the differences between IGA 4-0

Significant and Continuous Improvements Observed From Week 4 Through Week 123,4

Graph showing 38.4% improvement with SOOLANTRA vs 11.6% with vehicle QD from Week 4 through week 12.

Rapid and Dramatic Reduction in Inflammatory Lesion Count4

Graph showing a rapid and dramatic reduction in inflammatory lesion count at -20.5 with Soolantra vs -12.0 with vehicle QD.
  • Mean inflammatory lesion count reduction at week 12 was –20.5 (–64.9%) with SOOLANTRA Cream vs –12.0 (–41.6%) with vehicle (P<0.001)2
    • Mean inflammatory lesion count at baseline was 31 in both groups2
  • Significant inflammatory lesion count reductions continued throughout the entirety of the 12-week trial2

The most common adverse reactions (incidence ≤ 1%) included skin burning sensation and skin irritation.

Study Design

A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of SOOLANTRA Cream once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4), followed by a 40-week, investigator-blinded extension coparing the long-tern safety of SOOLANTRA Cream once daily with azelaic acid 15% gel twice daily in 622 subjects.

The efficacy and safety of SOOLANTRA Cream once daily was evaluated in subjects aged ≥18 years in 2 identically designed phase 3 clinical trials (N=1371). Final results were comparable between the 2 studies with the least favorable results presented here.

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

Woman with rosacea.

Not an actual patient

†Individual results may vary

The Results Are Clearer—Powerful inflammatory lesion reductions5

SUBJECT 009

Photos of study subject's progress at weeks 16, from baseline. IGA Score at baseline 3/moderate and lesion count of 22, week 16 0/clear and lesion count of 0.

IGA, Investigator’s Global Assessment.

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA (ivermectin) Cream, 1% once daily with MetroCream Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.5

SUBJECT 005

Photos of study subject's progress at weeks 16, from baseline. IGA Score at baseline 3/moderate lesion count of 22, week 16 1/ almost clear lesion count of 5.

IGA, Investigator’s Global Assessment.

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA (ivermectin) Cream, 1% once daily with MetroCream Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.5

SUBJECT 019

Photos of study subject's progress at weeks 16, from baseline. IGA Score at baseline 3/moderate lesion count of 69, week 16 1/ almost clear lesion count of 11.

IGA, Investigator’s Global Assessment.

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA (ivermectin) Cream, 1% once daily with MetroCream Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.5

Sample population representing treatment failure vs vehicle cream2

SUBJECT 006

Image showing subject at baseline with an IGA score of 4/severe and a lesion count of 37 and then at week 12 with an IGA score of 2/mild and a lesion count of 12.

IGA, Investigator’s Global Assessment.

A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of SOOLANTRA (ivermectin) Cream, 1% once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4).4

SUBJECT 008

Image showing subject at baseline with an IGA score of 4/severe and a lesion count of 55 and then at week 12 with an IGA score of 3/moderate and a lesion count of 17.

IGA, Investigator’s Global Assessment.

A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of SOOLANTRA (ivermectin) Cream, 1% once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4).4

SUBJECT 014

Image showing subject at baseline with an IGA score of 3/moderate and a lesion count of 28 and then at week 12 with an IGA score of 3/moderate and a lesion count of 14.

IGA, Investigator’s Global Assessment.

A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of SOOLANTRA (ivermectin) Cream, 1% once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4).4

SOOLANTRA Cream Long-Term Safety Study: Treatment Related AEs

  SOOLANTRA (ivermectin)
Cream, 1% ONCE DAILY (n=478)		 METROCREAM TOPICAL CREAM
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)

A greater percentage of subjects on vehicle/azelaic acid had treatment related AEs vs subjects using SOOLANTRA Cream
No severe or serious AEs were considered related to SOOLANTRA Cream or A2A. Five subjects in SOOLANTRA Cream group and 4 subjects in the AzA group discontinued from the study due to an AE during Part B. None of the AEs that led to discontinuation in the SOOLANTRA Cream group were considered related to SOOLANTRA Cream
*A Subject was counted once even if the subject experienced more than 1 AE during the study

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. Gold LS, et al. Efficacy and Safety of Ivermectin 1% Cream in Treatment of Papulopustular Rosacea: Results of Two Randomized, Double-Blind, Vehicle-Controlled Pivotal Studies. J Drugs Dermatol. 2014;13:316–323. 3. Stein Gold L, Kircik L, Fowler J, et al; Ivermectin Phase III Study Group. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316-323. 4. Data on file. Galderma Laboratories, L.P. 5. 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. 6. Deeks ED. lvermectin: a review in rosacea. Am J Clin Dermatol. 2015;16(5):447-452.

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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