PMID- 31985914
OWN - NLM
STAT- MEDLINE
DCOM- 20201105
LR  - 20210928
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 19
IP  - 1
DP  - 2020 Jan 1
TI  - Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne 
      Vulgaris: Results from Two Phase 3 Trials.
PG  - 70-77
LID - S1545961620P0070X [pii]
LID - 10.36849/JDD.2020.3977 [doi]
AB  - BACKGROUND: Tazarotene has been extensively studied in clinical trials and is 
      widely used to treat acne vulgaris (acne), with data suggesting that is one of 
      the most potent topical retinoids. Irritation from the cream, foam, and gel 
      formulations has limited its use in clinical practice. OBJECTIVE: To assess the 
      efficacy, safety, and tolerability of a unique tazarotene 0.045% lotion 
      formulation based on polymeric emulsion technology in subjects with moderate or 
      severe acne. Methods: A total of 1614 subjects, 9 years and older were randomized 
      to receive tazarotene 0.045% lotion or vehicle in two identical double-blind, 
      randomized, vehicle-controlled 12-week studies evaluating safety and efficacy 
      (inflammatory [papules and pustules] and noninflammatory [comedonal] lesion 
      counts and using Evaluator Global Severity Scores [EGSS]). Treatment success was 
      defined as at least a 2-grade improvement in EGSS and 'clear'/'almost clear' and 
      efficacy assessed through reduction in lesion counts. In addition, patients 
      completed a validated Acne-Specific Quality of Life (Acne-QoL) questionnaire. 
      Safety, adverse events (AEs), and cutaneous tolerability were assessed 
      throughout. RESULTS: Tazarotene 0.045% lotion demonstrated statistically 
      significant superiority to vehicle in reducing inflammatory and noninflammatory 
      lesion counts at week 12. Mean percent reductions in inflammatory and 
      noninflammatory lesions were 55.5% and 51.4% (Study 1, both P<0.001 versus 
      vehicle [45.7% and 41.5%, respectively]) and 59.5% and 60.0% (Study 2, both 
      P<0.001 versus vehicle [49.0% and 41.6%, respectively]), with tazarotene 0.045% 
      lotion at week 12. Treatment success was achieved by 25.5% (Study 1) and 29.6% 
      (Study 2) of subjects treated with tazarotene 0.045% lotion (both P<0.001 versus 
      vehicle [13.0% and 17.3%, respectively]). Improvements in QoL domain scores were 
      consistently greater with tazarotene. Tazarotene 0.045% lotion was 
      well-tolerated. The most common treatment-related AEs were application site pain 
      (5.3%), dryness (3.6%), and exfoliation (2.1%). CONCLUSION: Tazarotene 0.045% 
      lotion provides statistically significant greater efficacy than vehicle in terms 
      of lesion reduction and treatment success, with a highly favorable safety and 
      tolerability profile in moderate-to-severe acne patients. JJ Drugs Dermatol. 
      2020;19(1):70-77. doi:10.36849/JDD.2020.3977
FAU - Tanghetti, Emil A
AU  - Tanghetti EA
FAU - Werschler, William P
AU  - Werschler WP
FAU - Lain, Terry
AU  - Lain T
FAU - Guenin, Eric
AU  - Guenin E
FAU - Martin, Gina
AU  - Martin G
FAU - Pillai, Radhakrishnan
AU  - Pillai R
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Dermatologic Agents)
RN  - 0 (Nicotinic Acids)
RN  - 81BDR9Y8PS (tazarotene)
MH  - Acne Vulgaris/*drug therapy/pathology
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Dermatologic Agents/*administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nicotinic Acids/*administration & dosage
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Skin Cream
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2020/01/28 06:00
MHDA- 2020/11/06 06:00
CRDT- 2020/01/28 06:00
PHST- 2020/01/28 06:00 [entrez]
PHST- 2020/01/28 06:00 [pubmed]
PHST- 2020/11/06 06:00 [medline]
AID - S1545961620P0070X [pii]
AID - 10.36849/JDD.2020.3977 [doi]
PST - ppublish
SO  - J Drugs Dermatol. 2020 Jan 1;19(1):70-77. doi: 10.36849/JDD.2020.3977.