"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
Duac Topical Gel
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 397 subjects used DUAC Gel once daily for 11 weeks for the treatment of moderate to moderately severe facial acne vulgaris. All subjects were graded for facial local skin reactions (erythema, peeling, burning, and dryness) on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The percentage of subjects that had symptoms present before treatment (at baseline) and during treatment is presented in Table 1.
Table 1: Local Skin Reactions With Use of DUAC Gel
Combined Results From Five Trials (n = 397)
|Symptom||% of Subjects Using DUAC Gel With Symptom Present|
|Before Treatment (Baseline)||During Treatment|
|Burning||3%||< 1%||0||5%||< 1%||0|
|(Percentages derived by number of subjects receiving DUAC Gel with symptom score/number of enrolled subjects receiving DUAC Gel).|
The following adverse reactions have been identified during post approval use of DUAC Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Gel.
Read the Duac Topical Gel (clindamycin benzoyl peroxide) Side Effects Center for a complete guide to possible side effects
Avoid using DUAC Gel in combination with erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.
Concomitant Topical Medications
Concomitant topical acne therapies should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.
Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. DUAC Gel should be used with caution in patients receiving such agents.
Read the Duac Topical Gel Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/21/2014
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