The efficacy and safety of oral low dose naltrexone versus placebo in the patients with lichen planopilaris: a randomized controlled clinical trial

Lajevardi, Vahideh; Salarvand, Fereshteh; Ghiasi, Maryam; Nasimi, Maryam; Taraz, Mohammad

doi:10.1080/09546634.2020.1774488

Cited by 7 publications

(6 citation statements)

References 18 publications

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“…Both groups received topical clobetasol lotion. The only component that differed significantly between treatment groups was scalp erythema (but not perifollicular erythema) [13]. Our finding of reduced erythema is consistent with these two studies.…”

Section: Discussionsupporting

confidence: 90%

“…Patients were counseled about vivid dreams, sleep disturbance, and headaches, so this may have introduced bias. In a placebo-controlled randomized trial of low-dose naltrexone in LPP, reported side effects included sleep problems, anxiety, and headache, however the difference between naltrexone and control groups was not statistically significant [13]. Morning dosing of naltrexone has been suggested as a method of mitigating vivid dreams and sleep disturbances [12].…”

Section: Discussionmentioning

confidence: 99%

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Oral Low-Dose Naltrexone in the Treatment of Frontal Fibrosing Alopecia and Lichen Planopilaris: An Uncontrolled Open-Label Prospective Study

Hamel¹,

Chen²,

O’Connell³

et al. 2023

Cureus

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BackgroundFrontal fibrosing alopecia (FFA) and lichen planopilaris (LPP) is scarring alopecias with limited evidence supporting their treatment options. We investigated the use of low-dose naltrexone (3 mg oral daily) as adjunctive therapy in the treatment of FFA and LPP. MethodsA single-center, uncontrolled open-label prospective study was performed, with 26 patients who took lowdose naltrexone for one year included in the per-protocol analysis. Both patient-reported (pruritus and burning/pain) and physician-assessed (erythema, scale, and scalp involvement) outcomes were analyzed. ResultsThere were decreases in erythema and scale for the overall longitudinal outcomes using linear mixed effects model analysis. However, only erythema had a significant decrease at 12 months compared with baseline. Mean erythema decreased by 0.93 at 12 months compared with baseline on a 0-3-point scale (p<0.0001, 95% mean CI [-1.32, -0.53]). There was no statistically significant difference comparing 12 months to baseline for the other outcomes including pruritus, burning/pain, and scalp involvement. Limitations include the possibility of spontaneous stabilization, concurrent medications, a small sample size with limited racial diversity, and mild subjective symptoms at baseline. ConclusionOur study supports further investigation of oral low-dose naltrexone as adjunctive therapy in the treatment of FFA and LPP if there is prominent erythema, and possibly scale.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Oral Low-Dose Naltrexone in the Treatment of Frontal Fibrosing Alopecia and Lichen Planopilaris: An Uncontrolled Open-Label Prospective Study

Hamel¹,

Chen²,

O’Connell³

et al. 2023

Cureus

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“…In recent years, some studies have suggested that naltroxene at low doses (1‐5 mg) could be a potential alternative to the standard therapeutic regimen of scalp pruritus 54,55 . However, other studies using topical steroids combined with either 3 mg of naltroxene or placebo failed to show any significant difference in the improvement of LPP 56 . Up to 5 mg of naltroxene a day preserves its anti‐inflammatory properties; 57 thus, it could be a potential therapeutic option for patients with scalp dysesthesia; a large clinical study (NCT04409041) to test this hypothesis has started.…”

Section: Discussionmentioning

confidence: 99%

Current controversies in trichology: a European expert consensus statement

Meyer-Gonzalez¹,

Bacqueville

Grimalt

et al. 2021

Acad Dermatol Venereol

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Introduction Hair disorders are one of the most common conditions within dermatology practice but, although new diagnostic tools and therapeutic options have arisen, the management of these patients still represents a major clinical challenge. ObjectiveThis study aimed at gathering information and achieving consensus on relevant recommendations on the latest advances in alopecia, trichoscopy and hair dermocosmetics.Methods Experts of the steering committee consulted the available evidence on trichology-related areas from the past 5 years and formulated recommendations based on the evidence and their experience. A modified two-round Delphi procedure was performed among 45 European dermatologists experts in trichology to consult their degree of agreement on twenty recommendations, using a 4-point Likert scale. Consensus was defined as >80% of participants scoring either 1 (totally agree) or 2 (agree). ResultsIn the first round of the Delphi questionnaire, 75% of the recommendations reached consensus. Those that were not agreed upon were reformulated by the steering committee and voted again after an online meeting, where consensus was achieved in all recommendations.Conclusions All recommendations reached consensus after the two-round Delphi questionnaire and may be useful in clinical practice for dermatologists. The participants agreed that besides this consensus, further clinical studies are needed to assess the benefits of the emerging tools and treatments and to clarify the controversies that still exist in the field, aiming at improving patients' quality of life.

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“…Our search identified 411 records. The full text of 10 reports was assessed for eligibility, and it culminated in 7 studies eligible for inclusion [9][10][11][12][13][14][15] and 3 studies excluded for insufficient data [16] and different outcome measure [17,18]. The PRISMA study flow is presented in online supplementary file 1 (for all online suppl.…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

A Systematic Review and Bayesian Network Meta-Analysis of Medical Therapies for Lichen Planopilaris

Husein-ElAhmed,

Husein-ElAhmed

2023

Dermatology

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BACKGROUND: Lichen planopilaris (LPP) is a primary chronic lymphocytic cutaneous disorder that selectively destroys the hair follicles, resulting in a scarring alopecia. Unfortunately, current available treatments are not fully effective to stop hair loss, and the level of evidence for medical interventions is weak. METHODS: A systematic review and meta-analysis was performed including randomized trials that report the outcomes of lichen planopilaris activity index (LPPAI). These articles were pooled and a network meta-analysis (NAM) was conducted. RESULTS: A total of seven studies was identified and included in meta-analysis, comprising 251 LPP patients. The NMA showed the mean difference in LLPAI was significantly superior with the combination of clobetasol plus N-acetylcysteine (mean difference: -2.0, 95%CI=-3.43- -0.51) and the combination of clobetasol plus pentoxyfilline (mean difference: -1.62, 95%CI=-3.0- -0.25) compared to the treatment of reference (clobetasol). The NMA showed cyclosporine (mean difference: 2.05 95%CI= 0.68-3.49), methotrexate (mean difference: 1.95 95%CI= 1.23-3.17), the combination of methotrexate plus prednisolone (mean difference: 1.56 95%CI= 0.25-2.96) were significantly worse than hydroxychloroquine according to the differences in LLPAI. CONCLUSION: This work is the first NMA in LPP and hence, it can be helpful serving as an initial step towards better evidence-based decisions in the treatment of this challenging condition. We propose a triple combined approach consisting of topical clobetasol, hydroxychloroquine and N-acetylcysteine as resulted in the most effective approach. Considering the poor outcomes observed with pioglitazone, mycophenolate mofetil, and cyclosporine, it is advisable to contemplate the use of these medications in patients who have not responded adequately to more efficacious alternatives.

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The efficacy and safety of oral low dose naltrexone versus placebo in the patients with lichen planopilaris: a randomized controlled clinical trial

Cited by 7 publications

References 18 publications

Oral Low-Dose Naltrexone in the Treatment of Frontal Fibrosing Alopecia and Lichen Planopilaris: An Uncontrolled Open-Label Prospective Study

Oral Low-Dose Naltrexone in the Treatment of Frontal Fibrosing Alopecia and Lichen Planopilaris: An Uncontrolled Open-Label Prospective Study

Current controversies in trichology: a European expert consensus statement

A Systematic Review and Bayesian Network Meta-Analysis of Medical Therapies for Lichen Planopilaris

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