FDA News

FDA approves trifarotene cream for acne

The FDA recently approved Galderma’s topical retinoid cream, known as Aklief, for the treatment of acne vulgaris.

Additionally, the company reported positive safety profiles for Aklief in two phase 3 clinical trials on acne of both the face and trunk in patients aged 9 years and older, according to a news release issued by the company.

“While retinoids are foundational therapies to treat acne, there has been little innovation in decades,” Sandra Johnson, MD, FAAD, an investigator in the clinical trials and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas, said in a the release. “With the approval of Aklief cream, I am excited to offer my patients a unique, highly targeted retinoid that reduces inflammatory lesions on the face, back, chest and shoulders that has also been shown to be safe and well-tolerated.”

The approval of Aklief (trifarotene cream 0.005%) followed two identical phase 3 randomized, multicenter, parallel-group, double-blind, vehicle-controlled clinical trials for patients with moderate acne on the face and trunk. Researchers enrolled 2,420 patients to use the cream once daily for 12 weeks.

According to the manufacturer, inflammatory lesions reduced more quickly among patients using trifarotene cream compared with those using a vehicle, with a reduction observed at 2 weeks on the face and 4 weeks on the back, shoulders and chest (P < .05). Further, trifarotene cream was well-tolerated.

Patient with acne on face 
Source: Shutterstock

Adverse events included application site irritation, itching at the application site and sunburn.

“The approval of Aklief cream underscores our ability to bring new active molecules to the community and innovate even in well-established therapeutic classes. It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne,” Thibaud Portal PhD, global vice president of prescription at Galderma, said in the release. “We are pleased to add this new treatment option, with proven efficacy in facial and truncal acne, to our innovative and differentiated portfolio of acne treatments.”

Disclosures: Johnson has served as an investigator, speaker and consultant for Galderma. Portal is an employee of Galderma.

Editor's note: Johnson's disclosures have been corrected.

The FDA recently approved Galderma’s topical retinoid cream, known as Aklief, for the treatment of acne vulgaris.

Additionally, the company reported positive safety profiles for Aklief in two phase 3 clinical trials on acne of both the face and trunk in patients aged 9 years and older, according to a news release issued by the company.

“While retinoids are foundational therapies to treat acne, there has been little innovation in decades,” Sandra Johnson, MD, FAAD, an investigator in the clinical trials and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas, said in a the release. “With the approval of Aklief cream, I am excited to offer my patients a unique, highly targeted retinoid that reduces inflammatory lesions on the face, back, chest and shoulders that has also been shown to be safe and well-tolerated.”

The approval of Aklief (trifarotene cream 0.005%) followed two identical phase 3 randomized, multicenter, parallel-group, double-blind, vehicle-controlled clinical trials for patients with moderate acne on the face and trunk. Researchers enrolled 2,420 patients to use the cream once daily for 12 weeks.

According to the manufacturer, inflammatory lesions reduced more quickly among patients using trifarotene cream compared with those using a vehicle, with a reduction observed at 2 weeks on the face and 4 weeks on the back, shoulders and chest (P < .05). Further, trifarotene cream was well-tolerated.

Patient with acne on face 
Source: Shutterstock

Adverse events included application site irritation, itching at the application site and sunburn.

“The approval of Aklief cream underscores our ability to bring new active molecules to the community and innovate even in well-established therapeutic classes. It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne,” Thibaud Portal PhD, global vice president of prescription at Galderma, said in the release. “We are pleased to add this new treatment option, with proven efficacy in facial and truncal acne, to our innovative and differentiated portfolio of acne treatments.”

Disclosures: Johnson has served as an investigator, speaker and consultant for Galderma. Portal is an employee of Galderma.

Editor's note: Johnson's disclosures have been corrected.