The efficacy of 5% dapsone gel plus oral isotretinoin versus oral isotretinoin alone in acne vulgaris: A randomized double-blind study

Faghihi, Gita; Rakhshanpour, Mehrdad; Abtahi‐Naeini, Bahareh; Nilforoushzadeh, Mohammad Ali

doi:10.4103/2277-9175.139413

Cited by 17 publications

(12 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Among 2461 potential studies, 206 satisfied the inclusion criteria (eFigure in the Supplement). Among included trials, 163 (79%) were for acne and 43 (21%) were for rosacea. Rosacea RCTs were more likely to include at least 1 PROM (67% [n = 29 of 43]) compared with acne RCTs…”

Section: Resultsmentioning

confidence: 99%

Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

Miller

Tong

et al. 2022

JAMA Dermatol

View full text Add to dashboard Cite

ImportanceAcne and rosacea have substantial implications for quality of life, and it is therefore important to ensure the patient’s voice is being captured in pivotal randomized clinical trials (RCTs). Although patient-reported outcome measures (PROMs) are a valuable tool to capture the patient perspective, little is known about use of PROMs in RCTs on acne and rosacea.ObjectiveTo characterize the use of PROMs in RCTs on acne and rosacea.Evidence ReviewA systematic literature search was conducted using the search terms acne vulgaris and rosacea in the following databases: MEDLINE through PubMed, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. A modified search hedge for RCTs from the McGill Library was applied. All phase 2, 3, and 4 RCTs published between December 31, 2011, through December 31, 2021, that evaluated the efficacy and safety of therapies for acne and rosacea vs any comparator were eligible for inclusion.FindingsA total of 2461 publications describing RCTs were identified, of which 206 RCTs met the inclusion criteria (163 trials [79%] on acne and 43 [21%] on rosacea). At least 1 PROM was used in 53% of trials (110) included; PROM use was more common in rosacea RCTs (67% [n = 29]) compared with acne RCTs (50% [n = 81]). At least 1 dermatology-specific (13% [n = 27]) or disease-specific (14% [n = 28]) PROM was included in the RCTs analyzed. Only 7% of trials (14) included a PROM as a primary outcome measure. There was no statistically significant increase in PROM inclusion over the study period (11 of 21 trials in 2011 vs 5 of 12 trials in 2021).Conclusions and RelevanceIn this systematic review, PROMs were included in approximately one-half of acne and rosacea RCTs performed over the study period. In addition, PROMs were rarely used as a primary outcome measure, and inclusion of PROMs has not increased substantially over the past 10 years. Increasing use of PROMs in RCTs can ensure that the patient’s perspective is captured during the development of new treatments for acne and rosacea.

show abstract

Section: Resultsmentioning

confidence: 99%

Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

Miller

Tong

et al. 2022

JAMA Dermatol

View full text Add to dashboard Cite

show abstract

“… 40 It was approved for severe acne (conglobata and nodular-cystic), but evidence demonstrated in controlled randomized clinical trials (CRCTs) since 1980, in systematic reviews (SRs), consensuses, and recommendations of dermatology societies allowed to expand the indication for nodular-cystic and moderate papulopustular forms resistant to other treatments, with tendency to scarring, and emotional and social functional impairment. 1 , 2 , 36 , 38 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 A single course of the drug leads to cure in two-thirds of patients. Recurrences may take place, but they are milder and manageable with topical treatments.…”

Section: Resultsmentioning

confidence: 99%

Consensus on the use of oral isotretinoin in dermatology - Brazilian Society of Dermatology

Bagatin

Costa

Rocha

et al. 2020

Anais Brasileiros de Dermatologia

View full text Add to dashboard Cite

Background Isotretinoin is a synthetic retinoid, derived from vitamin A, with multiple mechanisms of action and highly effective in the treatment of acne, despite common adverse events, manageable and dose-dependent. Dose-independent teratogenicity is the most serious. Therefore, off-label prescriptions require strict criteria. Objective To communicate the experience and recommendation of Brazilian dermatologists on oral use of the drug in dermatology. Methods Eight experts from five universities were appointed by the Brazilian Society of Dermatology to develop a consensus on indications for this drug. Through the adapted DELPHI methodology, relevant elements were listed and an extensive analysis of the literature was carried out. The consensus was defined with the approval of at least 70% of the experts. Results With 100% approval from the authors, there was no doubt about the efficacy of oral isotretinoin in the treatment of acne, including as an adjunct in the correction of scars. Common and manageable common adverse events are mucocutaneous in nature. Others, such as growth retardation, abnormal healing, depression, and inflammatory bowel disease have been thoroughly investigated, and there is no evidence of a causal association; they are rare, individual, and should not contraindicate the use of the drug. Regarding unapproved indications, it may represent an option in cases of refractory rosacea, severe seborrheic dermatitis, stabilization of field cancerization with advanced photoaging and, although incipient, frontal fibrosing alopecia. For keratinization disorders, acitretin performs better. In the opinion of the authors, indications for purely esthetic purposes or oil control are not recommended, particularly for women of childbearing age. Conclusions Approved and non-approved indications, efficacy and adverse effects of oral isotretinoin in dermatology were presented and critically evaluated.

show abstract

“…Clinical evaluations were performed by acne lesion counts, the Global Acne Assessment Score (GAAS) 17. The severity of acne, based on the Global Acne Assessment Score (GAAS), was evaluated using a 5-point scale as follows: 0, clear; 1, almost clear; 2, mild; 3, moderate; 4, severe; and 5, very severe.…”

Section: Methodsmentioning

confidence: 99%

<p>Comparative Study Of Photodynamic Therapy With Riboflavin-Tryptophan Gel And 13% 5-Aminolevulinic Acid In The Treatment Of Mild To Moderate Acne Vulgaris</p>

Wangsuwan¹,

Meephansan²

2019

CCID

View full text Add to dashboard Cite

BackgroundNon-invasive photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) has been used as an alternative acne treatment for many years. Riboflavin and tryptophan are newly introduced photosensitizers.ObjectiveTo compare the efficacy of PDT with riboflavin-tryptophan (RT) gel with that of 13% ALA for the treatment of facial acne.MethodsWe performed a double-blind, split-face study of 37 subjects with mild to moderate facial acne vulgaris. RT gel was applied to half of the face, and 13% ALA was applied to the other half. Then, the whole face was irradiated using a blue light-emitting diode for 20 mins. Four treatment sessions were performed over a 4-week duration, at 1-week interval. The acne lesion counts and acne severity were assessed. Sebum secretion, Propionibacterium acne colonization, pore size, and skin texture were also evaluated.ResultsPDT with RT gel demonstrated good efficacy, non-inferior to ALA for acne treatment, with a significant reduction in acne lesion counts, severity grading, porphyrin, and sebum output. The pore size and skin texture were improved. Side-effects were minimal and well tolerated in all subjects.ConclusionPDT therapy with RT gel is an effective alternative treatment for acne vulgaris.

show abstract

The efficacy of 5% dapsone gel plus oral isotretinoin versus oral isotretinoin alone in acne vulgaris: A randomized double-blind study

Cited by 17 publications

References 9 publications

Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

Consensus on the use of oral isotretinoin in dermatology - Brazilian Society of Dermatology

<p>Comparative Study Of Photodynamic Therapy With Riboflavin-Tryptophan Gel And 13% 5-Aminolevulinic Acid In The Treatment Of Mild To Moderate Acne Vulgaris</p>

Contact Info

Product

Resources

About