Evaluation of Tolerance and Trichological Efficacy of a Food Supplement

• Sponsor: Derming SRL (Other)
• Overall Status: Completed
• CT.gov ID: NCT03272750
• Collaborator: (none)
• Enrollment: 51
• Arms: 3
• Actual Duration (Months): 4.8

Study Details

Study Description

Brief Summary

Controlled, randomized, double blind study, for the evaluation of tolerance and trichological efficacy of a food supplement: Bioscalin® new formulation versus reference formulation currently on the market and placebo

Condition or Disease	Intervention/Treatment	Phase
Telogen Effluvium	Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum; Dietary Supplement: Reference product; Dietary Supplement: Placebo	N/A

Detailed Description

Aim of the study was to evaluate clinically and by non-invasive instrumental measurements the trichological activity of a food supplement taken for 3 months by subjects of both sexes, aged between 18-60 years, affected by telogen effluvium, with a percentage of hair in anagen phase < 75%.

In particular the study foresaw the evaluation of the trichological activity of the Bioscalin® new formulation with Galeopsis Segetum in comparison to a reference product currently on the market and to placebo.

It was also aim of this study to evaluate treatment tolerance.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Controlled, Randomized, Double Blind Study, for the Evaluation of Tolerance and Trichological Efficacy of a Food Supplement: Bioscalin® New Formulation Versus Reference Formulation Currently on the Market and Placebo
• Actual Study Start Date: Nov 4, 2016
• Actual Primary Completion Date: Mar 31, 2017
• Actual Study Completion Date: Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bioscalin® new formulation with Galeopsis Segetum 2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table	Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum; Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of study product at lunch for the first 3 months of the trial.
Active Comparator: REFERENCE PRODUCT 2 reference product capsules + 1 placebo tablet	Dietary Supplement: Reference product; Total duration of the study was 4 months; each subject, took by mouth two capsules/die of reference product at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.
Placebo Comparator: PLACEBO 2 placebo capsules + 1 placebo tablet	Dietary Supplement: Placebo; Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.

Outcome Measures

Primary Outcome Measures

1. Change from baseline of the percentage of hair in anagen phase [Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).]

   Percentage of hair in anagen phase (anagen hair grow > 0,3 mm/die ) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.

2. Change from baseline of the hair density [Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).]

   Hair density (hair number/cm2) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.

3. Change from baseline of the percentage of vellus hair [Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).]

   Percentage of vellus hair (vellus hair has a diameter <0.04 mm)was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.

Secondary Outcome Measures

1. Hair parting test [Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).]

   Evaluation of hair thickening

2. Videodermatoscopy [Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).]

   Evaluation to visualize any morphological alteration/variation of the hair often imperceptible to the naked eye

3. Pull test [Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).]

   Evaluation of tensile strength of the hair

4. Sebometry [Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).]

   Measurement of surface lipid level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• both sexes;

• age range 18-60 years old;

• with telogen effluvium and a percentage of anagen ratio at inclusion < 75%;

• no-smokers;

• accepting to follow the instruction received by the investigator;

• disposable and able to return to the study centre at the established times;

• accepting to not change their habits regarding food, physical activity, hair and scalp cleansing;

• accepting to not receive any drugs/cosmetics treatment able to interfere with the study results;

• no participation in a similar study actually or during the previous 6 months;

• accepting to sign the Informed consent form.

Exclusion Criteria:

• Pregnancy (for female subjects);

• lactation (for female subjects);

• subjects not in menopause who does not use adequate contraceptive precautions in order to avoid pregnancies during the study;

• subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, after 2 (T2) and 3 (T3) month-treatment;

• change in the normal habits regarding food, physical activity, physical activity, hair and scalp cleansing during the month preceding the test;

• sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit). The product contains gluten (aroma of grain), then all subjects with celiac disease or gluten intolerance should be excluded.

• subjects whose insufficient adhesion to the study protocol is foreseeable;

• participation in a similar study actually or during the previous 6 months.

• presence of cutaneous disease on the tested area, as lesions, scars, malformations;

• clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).

• Diabetes

• endocrine disease

• hepatic disorder

• renal disorder

• cardiac disorder

• pulmonary disease

• cancer

• neurological or psychological disease

• inflammatory/immunosuppressive disease

• drug allergy

• anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);

• assumption of drugs able to influence the test results in the investigator opinion.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Derming SRL

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adele Sparavigna, Dermatologist, Principal Investigator, Derming SRL
• ClinicalTrials.gov Identifier: NCT03272750
• Other Study ID Numbers: E1416
• First Posted: Sep 6, 2017
• Last Update Posted: Sep 6, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 6, 2017