The researchers found that tretinoin 0.05% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and non-inflammatory lesion counts (both P<.001) at week 12, as well as improving acne severity (P<.001).
The approval was based on data from 2 large, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials involving patients with moderate to severe facial acne vulgaris.
The approval was based on 2 double-blind clinical trials involving 1640 patients 9 years of age and older with moderate to severe acne vulgaris.
The male patient presented in 2009 with a "3-year history of multiple interconnecting comedones in the axilla and inguinal regions, as well as scarring from previous lesions."
Treatment with the combination gel + oral doxycycline was associated with a 66.2% reduction in inflammatory lesions, a 58.7% reduction in non-inflammatory lesions, and a 62.6% reduction in total lesions at Week 12 vs baseline (P <.0001).
The researchers found that the probability of developing MDD was 18.5 and 12% among patients with acne and in the general population without acne over the 15-year follow-up period.
The researchers found that resistant mutants with the 23S rRNA mutation were not isolated when P. acnes mutants were exposed to clarithromycin after being incubated in broth without antimicrobials.
The researchers found that for the 52 patients completing the trial, there was a greater decrease in the mean ECCA score in the combination treatment group compared with the microneedling-only group.
Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes.
The researchers found that for patients currently receiving or having recently completed isotretinoin therapy, there was insufficient evidence to support delaying manual dermabrasion, superficial chemical peels, cutaneous surgery, laser hair removal, and fractional ablative and nonablative laser procedures.
The authors note that the tattooing was uneventful, but the patient presented with impaired tattoo healing. There was no infection, and with use of a proper moisturizer the tattoo eventually healed.
In 1 of the 2 trials the approval was based on patients in the Minolira group had a 43.1% mean improvement in inflammatory lesions vs. 31.7% of patients in the placebo group.
The researchers found that patients' out-of-pocket spending for topical steroids was $333.7 million. There was a 226.5% increase in total annual spending, from $237.6 million to $775.9 million.
The researchers found that in the group without acne, the bacterial community was enriched with genes related to bacterial metabolism, thought to be key in preventing harmful bacteria from colonizing the skin.
Cutanea Life Sciences has announced the availability of Aktipak (erythromycin and benzoyl peroxide) Gel, 3%/5% for the topical treatment of acne vulgaris.
Perrigo announced a recall of 10 lots of Clindamycin Phosphate and Benzoyl Peroxide Gel (1.2%/5%) due to the presence of a small amount of mold on the caps of the tubes.
Novan has announced results from its two Phase 3 trials of SB204 gel 4%, its investigational candidate for the treatment of acne vulgaris.
Factors that are associated with the appearance of acne in adult women include family history, personal history of acne, having no previous pregnancies, having hirsutism, and having a high level of psychological stress
Teva announced the availability of Rajani (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), the generic version of Bayer HealthCare's Beyaz.
Perrigo announced it has received tentative approval from the Food and Drug Administration (FDA) for Adapalene and Benzoyl Peroxide Gel, the generic version of Galderma's Epiduo Gel.
The Food and Drug Administration (FDA) has approved Differin Gel (adapalene; Galderma) 0.1% for over-the-counter (OTC) treatment for acne in patients aged ≥12 years.
A patient-reported study of hormonal contraceptives has found a significantly varied effect on acne among commonly prescribed agents.