Cutis
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Randomized Controlled Trial Multicenter Study
Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris.
The multiple etiologic factors involved in acne vulgaris make the use of several medications necessary to treat the condition. Use of a fixed combination of clindamycin phosphate 1.2% and tretinoin 0.025% in conjunction with a benzoyl peroxide (BPO) wash 4% targets several pathologic factors simultaneously and mitigates the potential for clindamycin-induced Propionibacterium acnes-resistant strains. New formulations may allow such regimens to be effectively used without overly reduced tolerability resulting from the irritation potential of tretinoin and BPO. ⋯ The frequency and severity of dryness, scaling, erythema, burning/stinging, and itching increased during the first week of treatment in both treatment arms but decreased thereafter. Local tolerability reactions were slightly more frequent in the CT gel + BPO wash group versus the CT gel + SFC group at week 1 but were generally mild and improved within 1 to 2 weeks. In conclusion, therapy with CT gel + BPO wash appears safe and well-tolerated in participants with mild to moderate acne vulgaris.
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Multicenter Study
Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study.
We conducted a prospective, multicenter, phase 3, open-label study to assess long-term sustained clearance of superficial basal cell carcinomas (sBCCs) treated with imiquimod cream 5%. A biopsy-confirmed tumor (area > or = 0.5 cm2 and diameter < or = 2.0 cm) was treated once daily 7 times per week for 6 weeks. Participants with initial clinical clearance at 12 weeks posttreatment were followed for 60 months. ⋯ Local skin reactions and application site reactions, the AEs reported by the most participants, occurred predominantly during the treatment period and resolved posttreatment. Compared to baseline, investigator-assessed SQA scores for the target tumor site improved for skin surface abnormalities and hyperpigmentation, and worsened for hypopigmentation. For low-risk sBCCs, daily application of imiquimod for 6 weeks had high initial and 5-year sustained clearance rates.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment.
This double-blind study compared the efficacy and tolerability of a combined oral contraceptive containing 30 microg ethinyl estradiol and 3 mg drospirenone (EE/DRSP; Yasmin) with a triphasic preparation containing 35 microg EE and 0.180, 0.215, 0.250 mg norgestimate (EE/NGM; Pramino, also known as Ortho Tri-Cyclen) in the treatment of acne vulgaris. The combined presence of antiandrogenic and antimineralocorticoid activities of drospirenone is unique to this novel progestin in that these characteristics most closely resemble those of progesterone. The study was designed to show that EE/DRSP was noninferior or superior to EE/NGM as to the relative decrease from baseline to cycle 6 in percentage of inflammatory and total lesion counts and the investigators' assessment of acne improvement. ⋯ Furthermore, both preparations increased the level of sex hormone-binding globulin (SHBG) and decreased the levels of androgens, changes typically associated with acne improvement. Both preparations were well tolerated. In conclusion, owing to the unique pharmacologic activities of drospirenone, the combined oral contraceptive EE/DRSP provides an effective treatment option in female patients with mild to moderate acne.
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Randomized Controlled Trial Multicenter Study Clinical Trial
The effect of 2 combined oral Contraceptives containing either drospirenone or cyproterone acetate on acne and seborrhea.
A new oral contraceptive has been developed that contains a unique progestogen, drospirenone (DRSP), and that has both antiandrogenic and antimineralocorticoid activity. Our objective was to compare the effect of 30 microg ethinyl estradiol (EE)/3 mg DRSP (EE/DRSP; Yasmin, Schering AG, Berlin, Germany) with that of 35 microg EE/2 mg cyproterone acetate (EE/CPA; Diane-35, Schering AG, Berlin, Germany) on mild-to-moderate cases of acne. Diane-35 is used worldwide (it is not on the market in the United States and Japan) as a hormone treatment for acne, with additional contraceptive benefits. ⋯ Subjective evaluation of the effect of treatment on facial acne by dermatologists, gynecologists, and the subjects themselves indicated an excellent or good improvement for most subjects in both groups. EE/DRSP has been shown to be as effective for treating mild-to-moderate acne as a preparation containing EE/CPA. This new preparation may provide useful hormone therapy for women with androgen-dependent disorders who also require contraception.