Hair Growth and Hair Loss Research article. research done both on male and female patients.

Clinical Evidence of Increase in Hair Growth and Decrease in Hair Loss without Adverse Reactions Promoted by Dniper Cosmetics® :

Study Design

An open, prospective, cohort (and with a unique branch phase IV) study was performed to evaluate the efficacy of Dniper Cosmetics® shampoo(s) in men and women with non cicatricial alopecia during a daily administration period of 10 months in accordance with the product prospectus.

The study was performed at the faculty of Hematology of Dnepropetrovsk state medical academy Ukraine (Альтернативная медицина) by :

Dr. Qaisar Ahmed MD, DHMS, Isl. Jurisprudence.

Dr. Marina Fedorovna MD.

Dr. Yuri Grigorovich Shevchenko MD.

under IQUIMEFA-UrBA-CONICET and LAT Research SRL guidance and supervision.

Patients of Decreased Hair Growth and Hair Loss Research Complaints :

Patients were recruited during a period of 10 months (Feb 2019 to December 2019).

Initially, the study sample comprised 96 volunteer patients; 32 women and 48 men.

Before enrolling in the trial, all patients were subjected to a complete clinical revision.

The following inclusion criteria were employed:

(1) age older than 18 years.

(2) dermatological diagnosis of non cicatricial alopecia.

(3) signed informed consent form.

Exclusion criteria were as follows:

• the appearance of any acute or chronic medical condition indicative of treatment discontinuation.
• known records of hypersensitivity to any of the excipients present in the product.
• Nonobservance of the clinical trial proceedings.
• Treatment with minoxidil or finasteride during the month previous to the clinical trial.
• Participation in any clinical trial within a month previous to the study.

Study Objectives and Assessments

Patients were treated with Dixe Hair-Regrowing Shampoo®  on a daily basis, once a day, during 90 consecutive days.

Two main variables were studied: efficacy in relation to hair growth promotion, thickness, overall hair volume, the effect on hair loss, and security and tolerability.  The efficacy was analyzed on 6th, 7th, 8th, and 9^th month after treatment.

To this end, patients and doctors fulfilled self-assessment questionnaires about the overall volume, appearance, and thickness of hair, and signals of hair growth at different times during the treatment period.

The effect on hair growth was determined by ocular inspections to determine the number of terminal hairs in the target area of the scalp.

To determine the effect on hair loss, patients were trained during the first visit of trial to count the hair fall after brushing for 1 min during 3 consecutive days with a fine-tooth comb. The number of fallen hairs was registered in the charts that were given to each patient.

Day 15 was considered the basal value. Therefore, to calculate the decrease in hair loss, the recounting of fallen hair between days 15 and 90 was considered.

Safety measures included spontaneous reports of adverse events and any adverse events disclosed during clinical evaluations. The incidence and type of adverse local effects were registered, as well as the severity and causality accounting for a lack of adherence to the protocol. Safety data were correlated to demographic data such as age and sex, clinical information such as acute or chronic health conditions, and concomitant treatment with other drugs.

The percentage of patients with adverse reactions was determined. The percentage of adverse reactions was correlated with those found in the literature, reported as frequent (1-10%) and very frequent (>10%).

Statistical Analysis

Several statistical tests were used: the Wilcoxon test for nonparametric median distribution of related samples, the Mann-Whitney U test, the Kolmogorov-Smirnov test, and the median test of independent samples.

The Wilcoxon test was used to analyze the medians of counted fallen hairs on day 15 and day 90, and to analyze the medians of the fallen hairs after brushing for 1 min during 3 consecutive days in women and men, and among individuals belonging to any age category.

The Mann-Whitney U test, the Kolmogorov-Smirnov test, and the median test of independent samples were used to analyze the differences between medians of counted fallen hairs of both women and men on day 90 and day 15, and among individuals belonging to any age category. p values <0.05 were considered significant.

Results and Efficacy “Hair Growth and Hair Loss Research” .

Evaluation of Efficacy: Overall Hair Volume, Appearance, Thickness, and Growth

To study the efficacy of Dixe Anti Hair Fall Shampoo®, patients were treated during nine months with the Dixe shampoo and evaluated on 6^th , 7^th , 8^th , and 9^th month; An increase in volume and thickness and an improvement in hair looks were considered changes of alopecia and analyzed by both the doctor and the patient.

Changes in alopecia assessed by doctors and patients. The graphics were constructed taking into account the percentage of patients with improved hair look during the treatment (on days 15, 30, 60, 90) according to doctors and patients.

On  9^th  month, the conclusions obtained by doctors and patients were statistically analyzed (median test for independent samples); patients and doctors agreed on the facts that the treatment was effective in 84.6% of patients and that there was an improvement in hair features. The null hypothesis that both agreed was affirmative (p = 0.056).

Furthermore, the variable hair looks at the end of treatment was analyzed. For this latter analysis, sex was taken into account to find that women and men improved their hair appearance by 92 and 85.2%, respectively.

In order to determine whether Dixe Anti Hair Fall/Hair lose Shampoo® induced hair growth, the number of new hairs over time was determined.

To this end, an ocular inspection was done with a magnifying glass in order to determine the number of terminal hairs in the target area of the scalp. Moreover, the percentage of patients with new hairs was scored.  The number of patients with new terminal hairs increased over time, reaching 84.6% at the end of treatment.

Effect of the shampoo (Dixe) on hair growth during the time of treatment. The percentage of patients that showed new terminal hair as a signal of hair growth during the treatment was determined.

Evaluation of Efficacy: Effect on Hair Growth Relation to Sex

The percentage of patients (men and women) who presented a decrease in hair loss was higher than in those who had an increase in hair loss or other categories. However, no significant differences were observed between the 2 groups analyzed.

The number of fallen hairs between 6^th  and  9^th  month was significantly different (p < 0.05; Wilcoxon test for nonparametric median distribution of related samples).

In order to determine whether the decrease in hair loss induced by the treatment was sex related, statistical analyses were carried out employing the Mann-Whitney U test, the Kolmogorov-Smirnov test, and the median test of independent samples.

No differences among the group medians were observed. However, when the fallen hairs, after brushing for 1 min during 3 consecutive days, were subjected to statistical analysis, significant differences (p < 0.05; Wilcoxon test for nonparametric median distribution of related samples) were observed in the medians of counted fallen hairs of women, who underwent a higher decrease (21%) compared with men.

Evaluation of Efficacy: Effect on Hair Growth and Hair Loss Research in Relation to Age

The effect of the Dixe Shampoo (anti hair fall/hair lose) on hair loss was studied in relation to age (<31 years, 31-45 years, and >45 years), evaluating the parameters explained above.

The percentage of patients with a decrease in hair loss was higher than the percentage of patients with an increase in hair loss between 5^th  and  9^th  month; however, no significant differences were found between age categories.

Evaluation of Efficacy: Effect on Dandruff Quantity at the End of Treatment

To determine the effect on dandruff quantity, each patient’s head was subjected to ocular inspection on day 90. As shown in ; low number of patients presented dandruff at the beginning of the study (only 7), but all of them had improved signs and symptoms at the end of the treatment.

Conclusions

It can be concluded that:

– Dixe Anti Hair Fall and Hair loss Shampoo® was demonstrated to improve hair looks in 84.6% of patients after nine months of treatment.

– The shampoo (Dixe) decreased hair loss from the beginning of treatment.

This effect was more marked in women. Best results were obtained in patients with androgenic alopecia sub types 1 and 2.

– Dixe Anti Hair Fall and Hair loss Shampoo® was also demonstrated to eliminate dandruff and was well tolerated.