A pilot single centre, double blind, placebo controlled, randomized, parallel study of Calmagen® dermaceutical cream and lotion for the topical treatment of tinea and onychomycosis

Abstract

BackgroundMost of the current anti-fungal treatments are chemical-based, fungistatic, have low efficacy in the treatment of tinea and toxicity concerns, while onychomycosis remains recalcitrant to most antifungal therapies. The study aimed to establish the fungicidal, efficacy and safety profile of Calmagen® dermaceutical cream and lotion containing AMYCOT® as a topical treatment in patients with severe to very severe presentations of fungal skin (tinea) and nail infections (onychomycosis).MethodsA randomized, placebo-controlled, double blind, parallel, single centre study was conducted on 28 subjects with severe to very severe tinea or onychomycosis. All patients were randomized in a ratio of 1:1 for treatment or placebo group. Subjects in the treatment arm received Calmagen® cream or lotion, while subjects in the placebo arm received a similar inert topical preparation. Tinea subjects were treated with cream for four weeks, while onychomycosis subjects were treated with lotion for 12 weeks. Mycological cure, the primary endpoint, was assessed by three parameters: KOH (potassium hydroxide) smear, fungal culture and live spore count. Clinical cure was defined as Investigator Global Assessment (IGA) response of ‘cleared’ or ‘excellent’.ResultsAll three parameters constituting mycological cure were confirmed in 92.8% (13/14) of subjects in the treatment arm, while all 14 subjects in the placebo arm remained positive for KOH smear. Calmagen® cream and lotion treatment showed a significant improvement in all three parameters: KOH smear, (95% CI (Calmagen): 79.4, 100.0; 95% CI (placebo): 0.0, 0.0; p < 0.0001); fungal culture (95% CI (Calmagen); 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019); and live spore count (95% CI (Calmagen): 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019). Clinical cure was achieved in all subjects in the treatment arm while none in the placebo arm were clinically cured. No treatment-related adverse effects were observed in either group.ConclusionsThe Calmagen® cream and lotion containing AMYCOT® represent a potentially safe and efficacious natural alternative in the treatment of Tinea and onychomycosis.Trial registrationThis trial has been registered with the clinical trial registry-India (CTRI; registration number: CTRI/2012/03/002522).

Complementary and Alternative Therapies for Onychomycosis: A Systematic Review of the Clinical Evidence

“…One open-label single-arm trial treated participants with Calmagen for 11 months and reported a clinical cure rate of 70% and partial clinical cure rate of 20% [11]. The second double-blind, randomized, controlled clinical trial compared Calmagen lotion to an inert placebo for a 12-week treatment course [13]. Authors found that patients receiving Calmagen achieved a 100% mycological cure rate and an improvement in their clinical severity score compared to the placebo group ( p = 0.0008).…”

“…The rest were variations of these two study designs. The number of study participants in clinical trials ranged from 10 to 400 participants [11][12][13]. Two studies included patients with a preexisting condition, one included patients with type 2 diabetes mellitus and the other included patients with HIV [14,15].…”

“…Ten studies included data on fungal species. Of those studies, four included only dermatophyte molds [13,[16][17][18], while the other six included a combination of dermatophyte molds, nondermatophyte molds, and/or yeasts [15,[19][20][21][22]. Treatment courses ranged from 8 weeks to 1 year [16,21], with the most common treatment course being 6 months.…”

Race reporting and representation in onychomycosis clinical trials: A systematic review

“…Of the 302 PubMed initial search results, 182 clinical trials (28,352 participants) met inclusion criteria and were included in the final analysis 6–186 . The PRISMA study selection process is detailed in Figure 1.…”

Botanicals and its extracts: Anew drug discovery and development paradigm for chronic and age-related illnesses

“…Spirulina extracts have also shown novel, anti-microbial activity as well as anti-inflammatory properties that can treat mild to severe fungal infections such as onychomycosis [13], viral infections [14] and some effects on the microbiome [15].…”