Indications and Usage

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 fda.gov/medwatch.

View full Prescribing Information

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 fda.gov/medwatch.

View Full Prescribing Information right left

Indications and Usage

Altreno® (tretinoin) Lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

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Indications and Usage

Important Safety Information

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.

See Less

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 fda.gov/medwatch.

View Full Prescribing Information right hover

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Proven inflammatory lesion reductions

Primary endpoints (over a 12-week period)

  • The mean absolute reduction in inflammatory lesion counts with Altreno Lotion was 13.1 vs 10.2 for vehicle
  • 16.5% of patients experienced treatment success* vs 6.9% with vehicle

Significant inflammatory facial lesion reductions at week 12

Significant inflammatory lesion reductions at week 12, Trial 1, 40.4% reduction for Vihicule (n=414), 50.9% reduction for Altreno Lotion (N=406) Significant inflammatory lesion reductions at week 12, Trial 1, 40.4% reduction for Vihicule (n=414), 50.9% reduction for Altreno Lotion (N=406)

Proven non-inflammatory lesion reductions

Primary endpoints (over a 12-week period)

  • The mean absolute reduction in non-inflammatory lesion counts with Altreno Lotion was 17.8 vs 10.6 for vehicle
  • 16.5% of patients experienced treatment success* vs 6.9% with vehicle

Significant non-inflammatory facial lesion reductions at week 12

Significant comedonal lesion reductions at week 12, Trial 1, 27.3% reduction for Vihicule (n=414), 47.5% reduction for Altreno Lotion (N=406) Significant comedonal lesion reductions at week 12, Trial 1, 27.3% reduction for Vihicule (n=414), 47.5% reduction for Altreno Lotion (N=406)

Adverse reactions reported by ≥1% of subjects treated with Altreno

In 2 randomized, double-blind, vehicle-controlled trials, subjects age 9 years and older applied ALTRENO or vehicle once daily for 12 weeks. The majority of subjects were White (74%) and female (55%). Approximately 47% were Hispanic/Latino and 45% were younger than 18 years of age. Adverse reactions reported by ≥1% of subjects treated with ALTRENO and more frequently than vehicle are summarized below.

 

Altreno (n=767)

Vehicle (n=783)

Application-site dryness

4%

< 1%

Application-site pain*

3%

< 1%

Application-site erythema

2%

< 1%

Application-site irritation

1%

< 1%

Application-site exfoliation

1%

< 1%

*Application-site pain was defined as application-site stinging, burning, or pain.

Application site tolerability reactions at any post baseline visit

Skin irritation was evaluated by active assessment of erythema, scaling, hypopigmentation, hyperpigmentation, itching, burning and stinging. The percentage of subjects who were assessed to have these signs and symptoms at any post-baseline visit are summarized below.

Mild     /     Moderate     /     Severe

Altreno (n=760)

Vehicle (n=782)

Erythema

51%

44%

Scaling

49%

30%

Hypopigmentation

12%

10%

Hyperpigmentation

35%

35%

Itching

35%

28%

Burning

30%

14%

Stinging

21%

8%

ADDITIONAL STUDIES

Post-hoc analysis of adult female patients with moderate acne

Inflammatory lesions in patients with moderate acne

Altreno Altreno

ADDITIONAL STUDIES

Post-hoc analysis of adult female patients with moderate acne

Non-inflammatory lesions in patients with moderate acne

Altreno Altreno

Treatment-emergent AE's (TAE) in moderate/severe treatment groups

Treatment related AEs reported by ≥1% patients

Altreno 0.05% lotion

Moderate adult female patients (n=240)

Altreno 0.05% lotion

Severe adult female patients (n=22)

Application site pain

7 (2.9%)

1 (4.5%)

Application site dryness

12 (5.0%)

1 (4.5%)

Application site erythema

4 (1.7%)

0 (0.0%)

Application site exfoliation

3 (1.3%)

0 (0.0%)

Application site pruritus

4 (1.7%)

0 (0.0%)

Actual patients from a clinical study after 12
weeks of treatment. Photos have not been
retouched. Individual results may vary.

 
Before Baseline
after Week 12
Before Baseline
after Week 12
Before Baseline
after Week 12
Before Baseline
after Week 12

Photos have not been retouched. Individual results may vary.

X

Prescribing Information

 
Altreno

Indications and Usage

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 fda.gov/medwatch.

View full Prescribing Information hover

 
Altreno

How Do I Get Altreno?

Altreno is a powerful Rx product, which means it requires a prescription. We can help you get in touch with a healthcare provider in two easy ways:

1. Online consultation
2. In-person visit

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Study Design

Study Design