Parekh 2017.
| Methods | RCT (parallel) Study design: Double blind Sample size calculation: Yes Diagnosis mycology: KOH and culture Big toenail specified: No Statistical comparisons for outcomes: Yes Duration of follow‐up: None Time points of measurements: 6 months Location: Apollo Clinic Bangalore, India |
|
| Participants | Total n: 10 with onychomycosis Age: 18 years of age and older Sex: 20 men and 8 women were initially randomised, sex ratio in final group unknown Inclusion criteria: Men and women, age 18 and older, diagnosed severe or very severe onychomycosis, confirmed with positive KOH smear, positive culture for a dermatophyte, and presence of live spores Exclusion criteria: Oral or topical tinea treatments 1 week prior to screening, consumption of any drug 1 week prior to, or during, the study that was judged to compromise the study, history of allergy or intolerance to any drug, pregnancy or lactation, participation in a clinical trial within the previous 30 days Disease duration: Unknown Comparable at baseline: Yes Causative species: dermatophytes Number of people lost to follow‐up: None Trial duration: March 27, 2010 ‐ January 31, 2011 |
|
| Interventions | Drug in study arm 1: Calmagen® lotion twice daily for 12 weeks, followed by once daily for an additional 12 weeks, n = 5 Drug in study arm 2: Placebo lotion twice daily for 12 weeks, followed by once daily for an additional 12 weeks, n = 5 |
|
| Outcomes | Mycological cure: KOH, culture, and live spore counts at 6 months Clinical cure: IGA response of cleared or excellent at 6 months Reduction in severity score of symptoms using SCIO at 6 months Improvement assessed by photographs at 6 months Adverse events: reported |
|
| Notes | 2 of 6 authors own stock in parent company of treatment. No other competing interests listed. The study was sponsored by industry. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomised...in a 1:1 ratio, according to a computer‐generated list by block randomisation" Comment: Specific randomisation method that is suitable was specified |
| Allocation concealment (selection bias) | Low risk | Quote: "The study coordinator kept one set of sealed envelopes containing the treatment codes" Comment: Treatment allocation was likely concealed as a centralised co‐ordinator controlled the randomisation table |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All patients and the investigator involved in conducting the study were blinded to treatment codes." Comment: It is likely that blinding was maintained |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: The investigator assessed clinical endpoints and was blinded to treatment codes. It is likely that blinding was maintained |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: No participants withdrew from the study. The ITT population was clearly specified |
| Selective reporting (reporting bias) | High risk | Comment: Addition of secondary outcome in the publication that was not included in the trial registry "IGA response". CTRI/2012/03/002522 |
| Other bias | Low risk | Comment: Not a multiple intervention trial, with all outcomes reported for interventions |