POWERFUL LESION REDUCTION
FOR EVEN MORE PATIENTS
Early results as soon as 2 weeks with consistent beneficial
results after 7 weeks1
Mean lesion reduction from two vehicle-controlled 12 week trials with acne
subjects using RETIN-A MICRO 0.1% once daily1
Non-inflammatory
*n=72; †n=71; ‡n=67
Inflammatory
*n=72; †n=71; ‡n=67
RETIN-A MICRO 0.1% was significantly superior to the vehicle
p<0.05
Mean lesion reduction from two vehicle-controlled 12 week trials with acne
subjects using RETIN-A MICRO 0.04% once daily1
Non-inflammatory
*n=108; †n=110; ‡n=111; ¶n=103
Inflammatory
*n=108; †n=110; ‡n=111; ¶n=103
p<0.05
FOR MORE PATIENTS THAN EVER
tolerability THEY SHOULD EXPECT
In a double-blind trial with 156 acne subjects comparing 12 weeks of treatment with RETIN-A MICRO (tretinoin) Gel, 0.04% or 0.1%, (78 subjects each group), the most frequently reported adverse events affected the skin and subcutaneous tissue (15.4% in the 0.04% group, and 20.5% in the 0.1% group). The most prevalent of the dermatologic adverse events in the 0.04% group was skin irritation (6.4%); and in the 0.1% group skin burning, (7.7%), erythema (5.1%), skin irritation (3.8%), and dermatitis (3.8%). Most adverse events were of mild intensity (63.4%), and 34.4% were moderate.
Throughout the treatment period the majority of subjects experienced some degree of irritation (mild, moderate, or severe) with 1% (2/225) of subjects having scores indicative of a severe irritation; 1.3% (3/225) of subjects treated with RETIN-A MICRO (tretinoin) Gel microsphere, 0.04%, discontinued treatment due to irritation, which included dryness in one patient and peeling and urticaria in another.
No more than 3% of subjects had cutaneous irritation scores indicative of severe irritation; 6% (14/224) of subjects treated with RETIN-A MICRO (tretinoin) Gel microsphere, 0.1%, discontinued treatment due to irritation. Of these 14 subjects, four had severe irritation after 3 to 5 days of treatment, with blistering in one subject.
RETIN-A MICRO should not be used on eczematous or sunburned skindue to potential for severe irritation.
Avoid use of RETIN-A MICRO with weather extremes, such as wind or colddue to potential for increased irritation.
FOR MORE PATIENTS THAN EVER
tolerability THEY SHOULD EXPECT
In a double-blind trial with 156 acne subjects comparing 12 weeks of treatment with RETIN-A MICRO (tretinoin) Gel, 0.04% or 0.1%, (78 subjects each group), the most frequently reported adverse events affected the skin and subcutaneous tissue (15.4% in the 0.04% group, and 20.5% in the 0.1% group). The most prevalent of the dermatologic adverse events in the 0.04% group was skin irritation (6.4%); and in the 0.1% group skin burning, (7.7%), erythema (5.1%), skin irritation (3.8%), and dermatitis (3.8%). Most adverse events were of mild intensity (63.4%), and 34.4% were moderate.
Throughout the treatment period the majority of subjects experienced some degree of irritation (mild, moderate, or severe) with 1% (2/225) of subjects having scores indicative of a severe irritation; 1.3% (3/225) of subjects treated with RETIN-A MICRO (tretinoin) Gel microsphere, 0.04%, discontinued treatment due to irritation, which included dryness in one patient and peeling and urticaria in another.
No more than 3% of subjects had cutaneous irritation scores indicative of severe irritation; 6% (14/224) of subjects treated with RETIN-A MICRO (tretinoin) Gel microsphere, 0.1%, discontinued treatment due to irritation. Of these 14 subjects, four had severe irritation after 3 to 5 days of treatment, with blistering in one subject.
RETIN-A MICRO should not be used on eczematous or sunburned skin due to potential for severe irritation.
Avoid use of RETIN-A MICRO with weather extremes, such as wind or cold due to potential for increased irritation.
MORE PATIENTS,
SAME DELIVERY SYSTEM
MORE PATIENTS, SAME DELIVERY SYSTEM
RETIN-A MICRO with Microsponge delivery system technology
• Helps control the release of product2
Pump-controlled dispensing
• Allows for consistent dosing at either strength1,3
• Designed with patients in mind
Results from a phase 4, open-label, multicenter, community-based study comparing RETIN-A-MICRO 0.04% vs. RETIN-A-MICRO 0.1%. At baseline, all patients in each of the subgroups had modiìed Global Acne Grade (mGAGS) scores indicating mild to moderate acne. At week 12, the mean mGAGs and the Investigator's Global Evaluation (IGE) demonstrated signiìcant (P<.0001) improvement from baseline for both concentrations, with 72% having at least moderate improvement. In approximately 25% of patients, acne was assessed as cleared or almost cleared3
Indication
RETIN-A MICRO® (tretinoin gel) microsphere is indicated for topical application in the treatment of acne vulgaris.
Important Safety Information
The skin of certain individuals may become excessively dry, red, swollen or blistered during the use of RETIN-A MICRO.
Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.
If warranted, patients should temporarily reduce the amount or frequency of application, or discontinue use temporarily or altogether. If a reaction suggesting sensitivity occurs, use should be discontinued.
Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of RETIN-A MICRO, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight with the use of tretinoin.
Patients should be encouraged to use a sunscreen with a SPF of 15 or higher and protective clothing over treated areas when exposure cannot be avoided.
Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.
The most common adverse reactions are skin pain, pruritus, skin irritation/subcutaneous irritation, pharyngitis, and erythema.
RETIN-A MICRO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and caution should be exercised in prescribing for nursing mothers. Safety and efficacy in patients under 12 have not been established.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please click here for full Prescribing Information.
References: 1. RETIN-A MICRO Gel Package Insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC. 2. Thielitz A, Gollnick H. Topical retinoids in acne vulgaris: update on efficacy and safety. Am J Clin Dermatol. 2008;9(6):369-381. 3. Eichenfield LF, Nighland M, Rossi AB, et al; PUMP Study Group. Phase 4 study to assess tretinoin pump for the treatment of facial acne. J Drugs Dermatol. 2008;71(12):1129-1136.
Microsponge is a registered trademark of AMCOL International Corporation.© 2023 Ortho Dermatologics affiliated entities. All Rights Reserved. RAM.0041.USA.18V5.0
CALIFORNIA RESIDENTS: DO NOT SELL MY PERSONAL INFORMATION
Indication
RETIN-A MICRO® (tretinoin gel) microsphere is indicated for topical application in the treatment of acne vulgaris.
Important Safety Information
The skin of certain individuals may become excessively dry, red, swollen or blistered during the use of RETIN-A MICRO.
Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.
If warranted, patients should temporarily reduce the amount or frequency of application, or discontinue use temporarily or altogether. If a reaction suggesting sensitivity occurs, use should be discontinued.
Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of RETIN-A MICRO, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight with the use of tretinoin.
Patients should be encouraged to use a sunscreen with a SPF of 15 or higher and protective clothing over treated areas when exposure cannot be avoided.
Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.
Most common adverse reactions are skin pain, pruritus, skin irritation/subcutaneous irritation, pharyngitis, and erythema..
RETIN-A MICRO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and caution should be exercised in prescribing for nursing mothers. Safety and efficacy in patients under 12 have not been established.
To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please click here for full Prescribing Information.
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