Place of preparation

Laboratory José F. Quiróz Pérez CIA.LTDA. “La Salud” Pharmacy (FLS), Guayaquil. Address: Mapasingue oeste Mz 48 Avenida 3era, entre la calle 2da y 3era, Guayaquil, Ecuador.

Laboratory materials

Morter. Beaker of 1000 ml. Beaker of 250 ml. and Computer and printer. All ingredients are purchased from the chemical market.

Preparation of the complete formula

Pulverize the alum in a mortar, crush the Sulphur and salicylic acid and mix all the powders in a 1000 ml beaker. In a 250 ml add petroleum jelly, bay leaf oil and add to the 100 ml beaker. Finally add the lard and mix until a homogeneous miss is obtained.

Quality control

Analysis of organoleptic properties (color, odor, appearance, and consistency), physical properties (determination of consistency), physical properties (determination of extensibility) of the final products.

Inclusion criteria

Patients receiving medical attention in Dermatology at the Teodoro Maldonado Carbo Hospital of the IESS Patients diagnosed with mild and moderate psoriasis in any of its locations with or without treatment. Over 12 years old. Patients who do not have malignant tumor pathology in the skin, autoimmune or other disabling pathologies.

Exclusion criteria

Patients who do not receive care in the Dermatology of the Teodoro Maldonado Carbo Hospital of the IESS. Patients corresponding to other skin pathologies. Patients under 12 years of age. Patients suffering from psychiatric disorders due to other pathologies that could interfere with the database and evaluation of quality of life. Patients with malignant tumor pathology in the skin, autoimmune or other disabling pathologies.

Approval of CIESH and TMC hospital

The research protocol was approved before the start of this work by the Institute of Research and Innovation of Integral Health of the Catholic University of Guayaquil, Ecuador. The informed consent was approved in the document Number HLV.DOF-CEISH-004 in January 31 of 2020, by the Research Ethics Committee of the Luis Vernaza Hospital in Guayaquil, Ecuador. The sampling of patients with psoriasis was approved by the management of the Luis Vernaza Hospital in Guayaquil in October 1 of 2021.

Selection of the sample

Our study population consisted of 173 patients from the Teodoro Maldonado Carbo Hospital with a diagnosis of psoriasis, 120 patients with mild and moderate psoriasis were selected by statistical calculation of population proportions with a margin of error of 5% and a confidence level of 95%. Of which 60 patients were randomly applied the new formula and 60 patients with corticosteroid as a control group.

Study design

This study was experimental clinical tries, randomized, double-blind controlled. Patients were asked to report any adverse event and concomitant medications since their previous visit. Additional safety assessments included PASI improvement response at 10 days after application.

Methodology clinical tries

The methodology used was a randomized, prospective, observational, descriptive, differential analytical clinical trial. For the interpretation of the results, descriptive and undifferentiated statistical tests were performed. Data visualization methods using histograms, normality curves and Q–Q plots and the Shapiro–Wilk normality test were used to assess the distribution of continuous variables with mean and standard deviation as measures of central tendency and dispersion for normally distributed variables, while the median and range were interquartile. Finally, to evaluate the differences between the means of the continuous variables, for those with normal distribution, the student’s t test was used, while the nonparametric Mann-Whitney U tests were used to show the differences between the medians of the abnormally distributed continuous variables. For categorical variables, Pearson’s chi-square test was used to assess the differences between them. All statistical and graphical analyses were performed using IBM SPSS Statistics for Windows, version 24 (IBM Corp., Armonk, N.Y., USA) and GraphPad Prism 8 version 8 (La Jolla, California, USA).

Phase I study: evaluation of hypersensitivity

It was carried out in 2019 at the intradomicile level in 100 healthy subjects, 5 formulas were elaborated with different components (Table 1), 20 subjects were randomly selected for each formulation, the application of the cream was on the back of the forearm, the control was carried out 24 h after its application. It was found that they did not present secondary reaction or hypersensitivity to any of the components of each formulation (Fig. 1).

Table 1 Hypersensitivity test in 100 healthy subjects with the 5 formulations and complete formula to psoriasis diseaseFig. 1

Patient with psoriasis evaluated before and after the application of the topical cream to psoriasis disease

Phase II study: randomized clinical trial with the complete formula (Fig. 2)Fig. 2

The protocol study: evaluation of a new topical cream in psoriasis: a randomized clinicla trial

Place and date of the clinical trial in patients with psoriasis

The selection of outpatients and their application was carried out in February to December 2022 from the Dermatology Service of the “Teodoro Maldonado Carbo” Hospital in the city of Guayaquil.

Clinical treatment

100% of patients live in a humid tropical climate with a temperature of 32 ℃+/−5, are affiliated to social security, in this study no systemic or biological treatments were administered to randomly selected patients.

Her oral treatment consisted of administering Vit D1 tablet daily, antihistamine, 1 tablet at night for pruritus. The cream with the complete formula was applied to group A, and the corticosteroid to group B, twice a day in the affected areas, the control was performed at 10 days after treatment.