Scientific articles

Scientific study by Professor Piraccini Maria Bianca in the journal
"Journal of Plastic and Pathology Dermatology"

L’Female Androgenetic Alopecia is a widespread disease that causes significant hair loss and which worsens as time progresses: it is not a seasonal condition (unlike some types of Telogen Effluvium), so the need to treat it becomes absolutely essential.

The study of Professor Maria Bianca Piraccini shows the effectiveness of a tablet supplement (Restax Donna) and a shampoo (Restax Shampoo Sebo Care) on a sample of 90 patients suffering from Androgenetic Alopecia and Telogen effluvium, all with a different clinical picture.

Following is an excerpt from the article:

Target

The objective of the study was to determine the efficacy and tolerability of tablet supplement treatment (Restax Donna®) combined with the use of a shampoo (Restax Shampoo®) for a period of time of 6 months, in the forms of telogen effluvium and mild-to-moderate female androgenetic alopecia, both in women of childbearing age and in peri-menopausal or menopausal women. The evaluation was collected through the judgment of both the practitioner and the patient by means of a questionnaire carried out first e after 6 months of treatment.

Materials and methods

Ninety female volunteer patients with telogen effluvium and mild-to-moderate androgenetic alopecia, aged 18 to 80 years, were included in the study.

Excluded from the study were those with neoplastic, systemic, and cutaneous malignant conditions or severe systemic conditions (diabetes, cirrhosis), subjects using cosmetic or drug therapies for androgenetic alopecia at least in the 6 months prior to or during the study, subjects with inflammatory scalp conditions, or pregnant and lactating women.

Patients were asked to take 1 cps of the supplement (Restax Donna®) 1 time a day and to use shampoo (Restax shampoo®) to wash their hair at least 3 times a week. The study had a duration of 6 months.

We wanted to test the efficacy and tolerability of the treatment by collecting the patient’s comment on subjective symptoms, and the physician’s judgment with comparative evaluation of the clinical evolution of the pathology through a questionnaire performed before and after 6 months of treatment.

At the first visit and after 6 months, the following was performed the pull test, rated on a scale of 0 to 3. Zero was assigned as negative, 1 as slightly positive, 2 as positive, and 3 as very positive.

The presence of trichodynia and pruritus were also evaluated. The trichodynia was evaluated with a score from 0 to 3. Zero value was absent; 1 moderate, 2 strong and value 3 was very strong.

The itching was evaluated with a scale from 0 to 3, where The value of zero was absent; 1 moderate, 2 strong, and the value of 3 was very strong. Evaluation on efficacy was conducted through the physician’s appreciation of the number of hairs per scalp follicular unit and hair diameter.

The researcher was asked to rate his or her satisfaction regarding number of hairs per follicular unit with a value scale between 0 and 3, where value 0 indicated very good satisfaction, value 1 good satisfaction, value 2 medium satisfaction, and value 3 poor satisfaction. A rating of hair diameter was also requested with a scale of values between 0 and 3, where value 0 indicated very good satisfaction, value 1 good satisfaction, value 2 medium satisfaction, and value 3 poor satisfaction.

The patient’s opinion of his or her current condition was also assessed based on values ranging from 0 to 3, where the value zero indicated very good satisfaction, value 1 good, value 2 average, and value 3 poor satisfaction.

Results

Ninety female patients with telogen effluvium and mild/moderate androgenetic alopecia were enrolled in the study, and all completed 6 months of therapy. The mean age of the patients was 44.1 years (range: 20-78). Of these patients 33 (36.67%) were postmenopausal. No major side effects were reported by the patients. The mean pull test at enrollment was 1.32, thus between slightly positive and positive. After 6 months of treatment, a significant decrease in hair loss was found in the patients, with mean pull test reduction of 86.55%. At the first visit, trichodynia was detected in 37 patients (41.1%) and mild-to-moderate itching in most patients (91.11%).At 6 months, trichodynia was reduced by 80.85% and itching by 72.74%.

At the beginning of the study, the average physician satisfaction with the number of hairs per follicular unit was 1.39, and the average hair diameter was 1.42, both values therefore considered to be between good and moderate. After 6 months of treatment, the investigator has shown improvement in the majority of patients expressing reassessment with very good or good satisfaction. In fact, the rating recorded a 72% improvement on hair number per follicular unit (mean value at 6 months 0.39) and 69.53% improvement on hair diameter (mean value at 6 months 0.43).

At the first visit, the average values of patient satisfaction with their hair tended to be close to 2 (average satisfaction), with a mean value of 1.87. After 6 months, patients were satisfied (mean value 0.56), with 69.64% improvement in consideration of their condition.

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