Potent doses combined with skin in mind
Low rates of discontinuation and stable tolerability over 12 weeks1,2
The efficacy, safety, and tolerability of TWYNEO cream were evaluated in two identically designed 12-week, randomized, double-blind, multicenter, vehicle-controlled, parallel-group Phase 3 trials (NCT03761810 / NCT03761784). Conducted at 63 centers across the United States between December 2018 and October 2019, the trials enrolled 858 subjects aged ≥9 years with moderate to severe inflammatory facial acne vulgaris, randomized 2:1 to once-daily E-BPO/T (n=571) or vehicle cream (n=287).
Eligible subjects had a baseline IGA (Investigator Global Assessment) score of 3 (moderate) or 4 (severe) on a 5-point scale (0=”clear” to 4=”severe”), with 20–100 inflammatory lesions (papules, pustules, and nodules), 30–150 non-inflammatory lesions (open and closed comedones), and no more than 2 facial cysts or nodules. Key exclusion criteria included acne conglobata, acne fulminans, or acne requiring systemic treatment. Study treatment was self-applied once daily to the face before bedtime after cleansing, with subjects evaluated at baseline and at Weeks 2, 4, 8, and 12.
The co-primary efficacy endpoints were (1) IGA success rate at Week 12, defined as a rating of “clear” (0) or “almost clear” (1) with at least a 2-grade improvement from baseline, and (2) absolute change in inflammatory and non-inflammatory facial lesion counts from baseline to Week 12. Secondary endpoints included percent change in lesion counts at Week 12 and absolute lesion count changes at Weeks 4 and 8.
Safety assessments included monitoring of TEAEs (treatment-emergent adverse events), physical examinations, and vital signs. Cutaneous safety (erythema, dryness, scaling, and pigmentation) and local tolerability (itching, burning, and stinging) were evaluated by investigators and subjects, respectively, at baseline and all post-baseline visits using a 4-point scale (0=”none” to 3=”severe”).
Investigator Global Assessment (IGA) score scale:2,3
- 0: Clear – Skin clear of inflammatory or non-inflammatory lesions
- 1: Almost clear – Rare non-inflammatory lesions alongside no more than one small inflammatory lesion
- 2: Mild – Some non-inflammatory lesions with a few inflammatory lesions but no nodular lesions
- 3: Moderate – More inflammatory and some non-inflammatory lesions with no more than one small nodular lesion
- 4: Severe – Numerous non-inflammatory and inflammatory lesions, including a few nodular lesions
Adverse reactions (≥1%) included pain, dryness, exfoliation, erythema, dermatitis, pruritus, and irritation (all at the application site)1
Most adverse reactions were mild or moderate1
Mean local tolerability scores (erythema, scaling, dryness, stinging, burning, and itching) remained below 1 (mild) throughout the 12-week treatment period in both Phase 3 trials.1 Local tolerability scores for erythema, scaling, dryness, itching, burning, and stinging rose during the first two weeks of treatment and decreased thereafter.1
References:
- TWYNEO (tretinoin and benzoyl peroxide) cream, 0.1%/3% [prescribing information]. Raleigh (NC): Mayne Pharma; revised 2025 Feb.
- Del Rosso J, Sugarman J, Green L, Lain T, Levy-Hacham O, Mizrahi R, Stein Gold L. Efficacy and safety of microencapsulated benzoyl peroxide and microencapsulated tretinoin for the treatment of acne vulgaris: results from two phase 3 double-blind, randomized, vehicle-controlled studies. J Am Acad Dermatol. 2023;89(4):719-27. doi: 10.1016/j.jaad.2023.05.093
- Kim HJ, Kim YH. Exploring acne treatments: from pathophysiological mechanisms to emerging therapies. Int J Mol Sci. 2024;25(10):5302. doi: 10.3390/ijms25105302
Important Safety Information
Indications and usage: TWYNEO cream is a combination tretinoin (0.1%), a retinoid, and benzoyl peroxide (3%) indicated for the topical treatment of acne vulgaris in adults and and pediatric patients 9 years of age and older.
Contraindications: History of serious hypersensitivity reaction to benzoyl peroxide or any component of TWYNEO.
Warnings and precautions:
- Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with use of benzoyl peroxide products.
- Skin irritation: Pain, dryness, exfoliation, erythema, and irritation may occur with use of TWYNEO. Avoid application of TWYNEO to cuts, abrasions, eczematous or sunburned skin.
- Photosensitivity: Minimize unprotected exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided.
Adverse reactions: The most common adverse reactions (incidence ≥1%) are pain, dryness, exfoliation, erythema, dermatitis, pruritus, and irritation (all at the application site).
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.