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European Journal of Dermatology : EJD Jul 2022Acne vulgaris is typically treated with a combination of a topical retinoid plus an antimicrobial agent, as recommended by national and international evidence-based... (Review)
Review
Acne vulgaris is typically treated with a combination of a topical retinoid plus an antimicrobial agent, as recommended by national and international evidence-based guidelines around the globe. Adapalene, a synthetic topical retinoid, is available in two concentrations (0.1% and 0.3%) and in once-daily fixed-dose combinations with benzoyl peroxide (BPO) 2.5%. Adapalene 0.3%/BPO 2.5% is approved for use for moderate-to-severe acne with proven efficacy, good safety and tolerability across a spectrum of patient variables (different ages, genders, and skin types) and disease severity. While some patients experience issues with transient tolerability during retinoid and BPO therapy, it is our clinical experience that good patient education to set expectations and provide strategies to minimize irritation can overcome the majority of issues. This article reviews the data supporting the use of adapalene 0.3%/2.5% in practice, including the complementary mechanism of action of adapalene and BPO, clinical data from a range of settings, and key aspects of patient education.
Topics: Humans; Female; Male; Adapalene; Dermatologic Agents; Naphthalenes; Drug Combinations; Gels; Benzoyl Peroxide; Acne Vulgaris; Retinoids; Treatment Outcome
PubMed: 36301750
DOI: 10.1684/ejd.2022.4275 -
Journal of Drugs in Dermatology : JDD Mar 2021Acne vulgaris is the most common dermatological disorder worldwide, causing significant physical and psychological morbidity. Topical combination therapy has shown... (Comparative Study)
Comparative Study Randomized Controlled Trial
Acne vulgaris is the most common dermatological disorder worldwide, causing significant physical and psychological morbidity. Topical combination therapy has shown superior efficacy compared to monotherapy, especially when combined with retinoids. Few studies have directly compared combined formulations. This evaluator-blinded pilot study compared the efficacy and tolerability of two marketed topical combination acne gels, clindamycin 1%-tretinoin 0.025% (CT) and benzoyl peroxide 2.5%-adapalene 0.1% (BA) in 20 patients with mild to moderate acne vulgaris. Gels were applied daily on opposite sides of the face for 21 days. The primary outcome was difference in transepidermal water loss (TEWL) at the end of treatment. Secondary endpoints were skin moisture content measurement, Investigators' Global Assessment, subject self-assessments (SSA) of burning/stinging, itching, erythema, and dryness/scaling, and Comparative Participant Satisfaction Questionnaire (CPSQ). Efficacy was assessed by inflammatory and non- inflammatory acne efflorescences counts. TEWL increased significantly for both CT and BA (+57.74%, P=0.002; +58.77%, P<0.001); skin moisture content significantly decreased only for BA (-16.47%, P=0.02). Only BA showed a significant increase in erythema and dryness/scaling (P=0.027 and P=0.014) and in SSA burning/stinging (P=0.04). Patient satisfaction evaluation also reflected the strong BA irritation. Although CT and BA both reduced acne lesions (P<0.001) and more patients preferred to continue with CT, subject perception of acne improvement was higher for BA. These findings suggest that CT and BA have similar efficacy in the treatment of mild to moderate papulopustular acne. However, CT was better tolerated than BA by both medical and subject evaluation. CT is an effective and tolerated treatment option.J Drugs Dermatol. 2021;20(3):295-301. doi:10.36849/JDD.2021.5641.
Topics: Acne Vulgaris; Adapalene, Benzoyl Peroxide Drug Combination; Administration, Cutaneous; Adolescent; Adult; Clindamycin; Dermatologic Agents; Drug Combinations; Erythema; Female; Gels; Humans; Male; Patient Satisfaction; Pilot Projects; Pruritus; Severity of Illness Index; Skin; Treatment Outcome; Tretinoin; Water Loss, Insensible; Young Adult
PubMed: 33683070
DOI: 10.36849/JDD.2021.5641 -
American Journal of Clinical Dermatology Jan 2022A three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug.
BACKGROUND
A three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance.
OBJECTIVES
We aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne.
METHODS
In a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed.
RESULTS
A total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8-30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6-26.8; noninflammatory, 21.8-30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity.
CONCLUSIONS
Once-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017).
Topics: Acne Vulgaris; Adapalene; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide; Child; Clindamycin; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Young Adult
PubMed: 34674160
DOI: 10.1007/s40257-021-00650-3 -
Pharmaceuticals (Basel, Switzerland) Aug 2020Adapalene (ADP) is a representative of the third retinoids generation and successfully used in first-line acne treatment. ADP binds to retinoic acid nuclear receptors.... (Review)
Review
Adapalene (ADP) is a representative of the third retinoids generation and successfully used in first-line acne treatment. ADP binds to retinoic acid nuclear receptors. The comedolytic, anti-inflammatory, antiproliferative, and immunomodulatory are the known ADP effects. Its safety profile is an advantage over other retinoids. ADP recently was found to be effective in the treatment of several dermatological diseases and photoaging besides the utility in the treatment of acne vulgaris. New biological effects of adapalene with therapeutic potential are highlighted in this review paper. Thus, adapalene could be a valuable therapeutic drug into the treatment of several types of cancer. Additionally, some neurodegenerative diseases could be treated with a suitable formulation for intravenous administration. The antibacterial activity against methicillin-resistant of an analogue of ADP has been proven. In different therapeutic schemes, ADP is more effective in combination with other active substances. New topical combinations with adapalene include ketoconazole (antifungal), mometasone furoate (anti-inflammatory corticosteroid), nadifloxacin (fluoroquinolone), and alfa and beta hydroxy acids. Combination with oral drugs is a new trend that enhances the properties of topical formulations with adapalene. Several studies have investigated the effects of ADP in co-administration with azithromycin, doxycycline, faropenem, isotretinoin, and valganciclovir. Innovative formulations of ADP also aim to achieve a better bioavailability, increased efficacy, and reduced side effects. In this review, we have highlighted the current studies on adapalene regarding biological effects useful in various treatment types. Adapalene has not been exploited yet to its full biological potential.
PubMed: 32872149
DOI: 10.3390/ph13090217 -
Expert Opinion on Drug Metabolism &... Dec 2009In the field of dermatology, topical retinoids represent a mainstay in acne treatment. Adapalene is a naphthoic acid derivative showing some pharmacological activities... (Review)
Review
BACKGROUND
In the field of dermatology, topical retinoids represent a mainstay in acne treatment. Adapalene is a naphthoic acid derivative showing some pharmacological activities similar to the regular retinoids. The drug is used singly or in combination for treating acne and a few other miscellaneous skin disorders.
OBJECTIVE
To critically review the pharmacokinetic, pharmacologic aspects and clinical benefits and adverse effects associated with topical adapalene.
METHOD
A systematic literature review was conducted primarily based on PubMed citations.
RESULTS/CONCLUSIONS
Adapalene shares some biological activities in common with retinoic acid. However, it exhibits distinct physicochemical and binding properties for selective retinoic acid receptors. In acne, adapalene is expected to reduce comedogenesis, expel mature comedones and exert some anti-inflammatory effects. The drug is effective as monotherapy in mild comedonal acne and in combination with benzoyl peroxide for mild-to-moderate inflammatory acne. The safety profile of adapalene is good. Indeed, only discrete to moderate adverse events including erytheme, xerosis, itching and stinging may develop during the early treatment phase. Clinical experience has established that adapalene represents a valuable addition to the other current treatments for acne.
Topics: Acneiform Eruptions; Adapalene; Animals; Clinical Trials as Topic; Dermatologic Agents; Humans; Naphthalenes; Skin Diseases
PubMed: 19929446
DOI: 10.1517/17425250903386269 -
American Journal of Clinical Dermatology Apr 2018Very few clinical trials have investigated the effect of topical acne treatment on scarring. (Comparative Study)
Comparative Study Randomized Controlled Trial
Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison.
BACKGROUND
Very few clinical trials have investigated the effect of topical acne treatment on scarring.
OBJECTIVES
Our objective was to evaluate the efficacy of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) in atrophic acne scar formation in patients with acne.
METHODS
In this multicenter, randomized, investigator-blinded, vehicle-controlled study, subjects with moderate or severe facial acne (Investigator's Global Assessment [IGA] score 3 or 4; ≥ 25 inflammatory lesions; ten or more atrophic acne scars) applied A0.3/BPO2.5 or vehicle daily per half face for 24 weeks. Subjects with acne requiring systemic treatment were excluded. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, IGA, skin roughness and skin texture, subject self-assessment of clinical acne-related scars and satisfaction questionnaire, tolerability, and safety.
RESULTS
Included subjects (n = 67) had mainly moderate acne (92.5% IGA 3); mean scores at baseline were approximately 40 acne lesions and 12 scars per half face. By week 24, the change from baseline in total scar count was - 15.5% for A0.3/BPO2.5 versus + 14.4% for vehicle (approximately 30% difference), with a mean of 9.5 scars versus 13.3 per half face, respectively (p < 0.0001). For SGA at week 24, a total of 32.9% with A0.3/BPO2.5 versus 16.4% with vehicle (p < 0.01) were clear/almost clear. Inflammatory acne lesions decreased by 86.7% for A0.3/BPO2.5 versus 57.9% for vehicle (p < 0.0001), and 64.2 versus 19.4% of subjects, respectively, were IGA clear/almost clear (p < 0.0001) at week 24. Treatment-related AEs were reported by 20.9% for A0.3/BPO2.5 versus 9% for vehicle side, most commonly skin irritation (14.9 vs. 6%, respectively).
CONCLUSIONS
Topical A0.3/BPO2.5 prevented and reduced atrophic scar formation. Scar count increased with vehicle (+ 14.4%) but decreased with A0.3/BPO2.5 (- 15.5%) over 24 weeks.
TRIAL REGISTRY
ClinicalTrials.gov identifier NCT02735421.
Topics: Acne Vulgaris; Adapalene; Administration, Cutaneous; Adolescent; Adult; Atrophy; Benzoyl Peroxide; Cicatrix; Dermatologic Agents; Double-Blind Method; Drug Combinations; Face; Female; Gels; Humans; Male; Severity of Illness Index; Skin; Treatment Outcome; Young Adult
PubMed: 29549588
DOI: 10.1007/s40257-018-0352-y -
Skin Pharmacology : the Official... 1993Adapalene is a novel chemical entity which, in terms of pharmacology, behaves similar to tretinoin, but is chemically and photochemically stable. It has a particular... (Review)
Review
Adapalene is a novel chemical entity which, in terms of pharmacology, behaves similar to tretinoin, but is chemically and photochemically stable. It has a particular selectivity profile for the known nuclear retinoic acid receptors with low affinity for RAR alpha and no transactivating potential for RXR alpha. This receptor profile could imply that adapalene, in contrast to tretinoin, affects the terminal differentiation pathway of epidermal cells rather than their proliferation. Furthermore, adapalene does not bind to members of the cellular retinoic acid binding protein family. Adapalene has comedolytic activity in the topical rhino mouse model. It exerts a moderate-to-potent anti-inflammatory effect in a series of in vitro and in vivo models. In comparative clinical studies involving 72 acne patients, the efficacy of adapalene was comparable, if not superior, to tretinoin, but adapalene was better tolerated. The data reviewed in this paper indicate that adapalene should be particularly beneficial in the treatment of acne.
Topics: Acne Vulgaris; Adapalene; Administration, Topical; Animals; Anti-Inflammatory Agents, Non-Steroidal; Humans; Mice; Naphthalenes; Retinoids
PubMed: 8142113
DOI: 10.1159/000211165 -
JPMA. the Journal of the Pakistan... Oct 2023
Topics: Humans; Adapalene; Acne Vulgaris; Anti-Inflammatory Agents, Non-Steroidal; Melanoma; Gels; Treatment Outcome; Dermatologic Agents
PubMed: 37876097
DOI: 10.47391/JPMA.8438