SIGNIFICANT COMEDONAL LESION REDUCTIONS AT WEEK 121,2

TRIAL 1: Mean Percent Reduction

TRIAL 1 Mean Percent Reduction

Trial 1 Primary Endpoints1,2

  • The mean absolute reduction in comedonal lesion counts with ALTRENO lotion was 17.8 vs 10.6 for vehicle (P<0.001)
  • 16.5% of patients experienced treatment success* vs 6.9% with vehicle (P<0.001)

Study Description

Results of a phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing the efficacy and safety of ALTRENO lotion once daily for 12 weeks to vehicle in patients 9 years and older to moderate-to-severe acne vulgaris (baseline 20 to 100 comedonal lesions).1,2

TRIAL 2: Mean Percent Reduction

TRIAL 2 Mean Percent Reduction

Trial 2 Primary Endpoints1,2

  • The mean absolute reduction in comedonal lesion counts with ALTRENO lotion was 21.9 vs 13.9 for vehicle (P<0.001)
  • 19.8% of patients experienced treatment success* vs 12.5% with vehicle (P=0.007)

Study Description

Results of a phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing the efficacy and safety of ALTRENO lotion once daily for 12 weeks to vehicle in patients 9 years and older with moderate-to-severe acne vulgaris (baseline 20 to 100 comedonal lesions).1,2

INDICATION

ALTRENO™ (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION

ALTRENO is for topical use only. Not for ophthalmic, oral, or intravaginal use.

Skin Irritation: Patients using ALTRENO may experience application site dryness, pain, erythema, irritation, and exfoliation. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of ALTRENO, or discontinue use. Avoid application of ALTRENO to eczematous or sunburned skin.

Ultraviolet Light and Environmental Exposure: Minimize unprotected exposure to ultraviolet light, including sunlight and sunlamps. Warn patients with frequent sun exposure and those with inherent sensitivity to sunlight to exercise caution. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

Fish Allergies: ALTRENO contains soluble fish proteins. Use with caution in patients with known sensitivity or allergy to fish. Advise patients to contact their healthcare provider if they develop pruritus or urticaria.

Adverse Reactions: The most common adverse reactions in clinical trials were application site dryness (4%), pain (3%), erythema (2%), irritation (1%) and exfoliation (1%).

Nursing Women: It is not known whether topical administration of tretinoin could result in sufficient systemic absorption to produce detectable concentrations in human milk. The developmental health benefits of breastfeeding should be considered along with the mother’s clinical need for ALTRENO and any potential adverse effects on the breastfed child from ALTRENO.

To report SUSPECTED ADVERSE REACTIONS, contact Customer Service at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information.

References:

  • ALTRENO lotion [package insert]. Bridgewater, NJ: Ortho Dermatologics.
  • Data on file. Ortho Dermatologics.

FOR HEALTHCARE PROFESSIONALS

This website is intended for US healthcare professionals only.

ENTER HEALTHCARE PROFESSIONAL SITE
GO TO PATIENT SITE