Differin Cream
Name: Differin Cream
Indications
DIFFERIN® Cream is indicated for the topical treatment of acne vulgaris.
Clinical Studies
Two vehicle-controlled clinical studies were conducted in patients 12 to 30 years of age with mild to moderate acne vulgaris, in which DIFFERIN® Cream was compared with its vehicle. Patients were instructed to apply their treatment medication once daily at bedtime for 12 weeks. In one study patients were provided with a soapless cleanser and were encouraged to refrain from using moisturizers. No other topical medications, other than DIFFERIN® Cream, were to be applied to the face during the studies. DIFFERIN® Cream was significantly more effective than its vehicle in the reduction of acne lesion counts. The mean percent reduction in lesion counts from baseline after treatment for 12 weeks are presented in the following table:
| MEAN PERCENT REDUCTION IN LESION COUNTS FROM BASELINE TO WEEK 12 | ||||
| Efficacy Variable | Study No. 1 | Study No. 2 | ||
| Adapalene Cream, 0.1% N=119 | Cream Vehicle N=118 | Adapalene Cream, 0.1% N=175 | Cream Vehicle N=175 | |
| Non-inflammatory lesions | 34% | 18% | 35% | 15% |
| Inflammatory lesions | 32% | 17% | 14% | 6% |
| Total lesions | 34% | 18% | 30% | 15% |
The trend in the Investigator's global assessment of severity supported the efficacy of DIFFERIN Cream when compared to the cream vehicle.
Warnings
No information provided.
Overdose
DIFFERIN® Cream is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. The acute oral toxicity of DIFFERIN® Cream in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
Clinical pharmacology
Mechanism Of Action
Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.
Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Pharmacokinetics
Absorption of adapalene from DIFFERIN® Cream through human skin is low. In a pharmacokinetic study with six acne patients treated once daily for 5 days with 2 grams of DIFFERIN® Cream applied to 1000 cm² of acne involved skin, there were no quantifiable amounts (limit of quantification = 0.35 ng/mL) of adapalene in the plasma samples from any patient. Excretion appears to be primarily by the biliary route.
Related health
- Acne (Pimples)
- Cystic Acne
Differin Cream - Clinical Pharmacology
Mechanism of Action
Adapalene acts on retinoid receptors. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.
Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Pharmacokinetics
Absorption of adapalene from DIFFERIN® Cream through human skin is low. In a pharmacokinetic study with six acne patients treated once daily for 5 days with 2 grams of DIFFERIN® Cream applied to 1000 cm2 of acne involved skin, there were no quantifiable amounts (limit of quantification = 0.35 ng/mL) of adapalene in the plasma samples from any patient. Excretion appears to be primarily by the biliary route.
Overdosage
DIFFERIN® Cream is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. The acute oral toxicity of DIFFERIN® Cream in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
How supplied
DIFFERIN® (adapalene) Cream, 0.1% is supplied in the following size:
45 g tube – NDC 0299-5915-45
Storage: Store at controlled room temperature 68° to 77°F (20°-25°C), with excursions permitted between 59° and 86°F (15°-30°C). Protect from freezing.
Marketed by:
GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA
Manufactured by:
G Production Inc.
Baie d'Urfé, QC
H9X 3S4 Canada
Made in Canada.
GALDERMA is a registered trademark.
www.differin.com
P50448-1
Revised: November 2011