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Galderma Announces Publication of Pivotal Phase 3 PERFECT 1 and PERFECT 2 Clinical Trials of Trifarotene in Patients with Moderate Facial and Truncal Acne in the Journal of the American Academy of Dermatology

FORT WORTH, Texas, Feb. 28, 2019 /PRNewswire/ -- Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that results from the pivotal Phase 3 PERFECT 1 and PERFECT 2 clinical trials of once-daily trifarotene 50 µg/g cream in patients with moderate acne on the face and trunk were published online in the Journal of the American Academy of Dermatology.1,2 Trifarotene, an investigational drug, is an innovative new molecule and a unique retinoid receptor agonist that selectively targets retinoic acid receptor gamma (RAR-γ).1 The publication, titled "Randomized Phase 3 Evaluation of Trifarotene 50 µg/g Cream Treatment of Moderate Facial and Truncal Acne," can be accessed here.

The two identical multicenter, randomized, 12-week clinical trials of more than 2,400 patients met all primary and secondary efficacy endpoints, including Investigator Global Assessment (IGA/facial acne), changes in inflammatory and non-inflammatory lesion counts and Physician Global Assessment (PGA/truncal acne).1,2 The majority of adverse events were local cutaneous irritation mainly during the first weeks of treatment, which improved thereafter.3

Data from the two trials were included in a New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) for trifarotene for the treatment of facial and truncal acne.

"Acne frequently affects both the face and trunk and can cause permanent scarring.4,5 Many patients with facial and truncal acne feel self-conscious and are often reluctant to engage with other people," said Howard Marsh, M.D., Vice President of Medical Affairs at Galderma, USA.6,7 "Despite the negative outcomes experienced, truncal acne has been insufficiently studied."4

"PERFECT 1 and PERFECT 2 are the first and only large-scale randomized trials to evaluate a topical retinoid for the treatment of both facial and truncal acne," said Thibaud Portal, Vice President of Prescription, Strategy and Innovation Group at Galderma.1,2 "This underscores Galderma's commitment to innovation, the dermatology community and patients, and we are excited about the potential of trifarotene and its novel features. We hope to bring this next-generation topical retinoid to patients suffering from acne as soon as possible."

About the PERFECT 1 and PERFECT 2 Study
The two randomized, double-blind, vehicle-controlled studies evaluated the efficacy and safety of once-daily trifarotene 50 µg/g cream compared with vehicle cream over 12 weeks.3 Patients aged nine years or older with moderate acne vulgaris on the face and trunk (mean age: 19 years) were randomized to once-daily trifarotene 50 µg/g cream or vehicle cream at bedtime.3 A total of 200 sites in the United States, Canada, Europe and Russia enrolled 2,420 patients.1-3

The three co-primary efficacy endpoints were IGA success rate on the face (clear/almost clear and at least a 2 grade improvement from baseline) at week 12, and absolute change from baseline in facial inflammatory and non-inflammatory lesion counts from baseline to week 12.3 The three secondary efficacy endpoints were Physician Global Assessment (PGA) success rate on the trunk (clear/almost clear and at least a 2 grade improvement from baseline) at week 12, and absolute change in truncal inflammatory and non-inflammatory lesion counts from baseline to week 12.3 Safety was assessed through recording of adverse events, local tolerability, vital signs and routine laboratory testing.3

About Trifarotene
Trifarotene, a new molecule, is a unique retinoic acid receptor agonist.1 Its activity is highly targeted to the skin.1 Preclinical data have shown that trifarotene has a long half-life in keratinocytes and a short half-life in hepatic cells.3 Trifarotene is in clinical development for the treatment of both moderate facial and truncal acne, including large body surface areas.3

About Acne
Acne is the most common skin condition in the United States, affecting up to 50 million Americans annually and approximately 85 percent of young people.5 An inflammatory disease, acne occurs when a combination of sebum (oil) and dead skin cells clog pores, allowing the bacteria associated with acne (p. acnes) to grow.5,8 Acne on the face is the most common and often the most visible presentation of the disease; however, back and chest acne have been estimated to occur in 61 percent and 45 percent of acne patients, respectively.4,5 Back acne, once thought to be a predominantly male disease, has shown to be prevalent in females.9 Acne can leave physical scars as well as psychological and emotional scars, including negative impacts on self-image and psychological well-being, anxiety, depression, lower self-esteem and negative emotions.5,6,10

About Galderma
Galderma, Nestlé Skin Health's medical solutions business, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. Galderma is a leader in the research and development of scientifically-defined and medically-proven solutions for the skin. Partnering with health care practitioners around the world to meet the skin health needs of people throughout their lifetime, the company contributes to Nestlé Skin Health's vision to change the way the world thinks about skin health. For more information, please visit www.galderma.com.

Contacts:
Shannon Iwaniuk
Corporate Communications, Galderma Laboratories, L.P.
shannon.iwaniuk@galderma.com

Sara Schwartz
Media Relations, Twist Mktg
sschwartz@twistmktg.com

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1 Data on File, Galderma.
2 Data on File, Galderma.
3 Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, et al. Randomized Phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal ACNE. J Am Acad Dermatol. 2019.  DOI: https://doi.org/10.1016/j.jaad.2019.02.044.
4 Tan JK, Tang J, Fung K, Gupta AK, Thomas DR, et al. Prevalence and severity of facial and truncal acne in a referral cohort. J Drugs Dermatol. 2008;7(6):551-556.
5 American Academy of Dermatology. Acne. https://www.aad.org/media/stats/conditions. Accessed February 25, 2019.
6 Tan J, Thiboutot D, Gollnick H, Kang S, Layton A, et al. Development of an atrophic acne scar risk assessment tool. J Eur Acad Dermatol Venereol. 2017;31:1547-1554.
7 Hazarika N, Archana M. The psychosocial impact of acne vulgaris. Indian J Dermatol. 2016; 61(5):515-520.
8 Mayo Clinic. Acne. https://www.mayoclinic.org/diseases-. conditions/acne/symptoms-causes/syc-20368047. Accessed February 25, 2019.
9 Del Rosso JQ. Truncal acne vulgaris: the relative roles of topical and systemic antibiotic therapy. J Drugs Dermatol. 2007;6:148-51.
10 Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998;139(5):846-850.

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