Telogen EffluviumNCT03272750
Evaluation of Tolerance and Trichological Efficacy of a Food Supplement
A study testing Bioscalin® new formulation with Galeopsis Segetum and Reference product in people with Telogen Effluvium, run by Derming SRL.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Telogen Effluvium
- What is being tested?
- Bioscalin® new formulation with Galeopsis Segetum and Reference product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
Read the 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.
- Conditions
- Telogen Effluvium
- Being tested
- Bioscalin® new formulation with Galeopsis Segetum, Reference product, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioscalin® new formulation with Galeopsis SegetumDietary supplement
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.
Reference productDietary supplement
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.
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Bioscalin® new formulation with Galeopsis Segetum | Experimental | 2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table Receives: Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum |
| REFERENCE PRODUCT | Active comparator | 2 reference product capsules + 1 placebo tablet Receives: Dietary Supplement: Reference product |
| PLACEBO | Placebo comparator | 2 placebo capsules + 1 placebo tablet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the percentage of hair in anagen phase
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.
Measured: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
Change from baseline of the hair density
Hair density (hair number/cm2) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.
Measured: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
Change from baseline of the percentage of vellus hair
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.
Measured: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
Secondary outcomes (4)
Hair parting test
Evaluation of hair thickening
Measured: 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).
Videodermatoscopy
Evaluation to visualize any morphological alteration/variation of the hair often imperceptible to the naked eye
Measured: 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).
Pull test
Evaluation of tensile strength of the hair
Measured: 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).
Sebometry
Measurement of surface lipid level
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start4 Nov 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telogen EffluviumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272750
- Sponsor's protocol ID
- E1416
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03272750
- Acronym / sponsor ID
- E1416
- Conditions
- Telogen Effluvium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bioscalin® new formulation with Galeopsis Segetum | Experimental | Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table |
| REFERENCE PRODUCT | Active comparator | Dietary Supplement: Reference product2 reference product capsules + 1 placebo tablet |
| PLACEBO | Placebo comparator | Dietary Supplement: Placebo2 placebo capsules + 1 placebo tablet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioscalin® new formulation with Galeopsis SegetumTotal 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. | Dietary supplement | Bioscalin® new formulation with Galeopsis Segetum |
| Reference productTotal 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. | Dietary supplement | REFERENCE PRODUCT |
| PlaceboTotal 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. | Dietary supplement | PLACEBO |
Primary outcome
Change from baseline of the percentage of hair in anagen phase
Time frame: 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.
Change from baseline of the hair density
Time frame: 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.
Change from baseline of the percentage of vellus hair
Time frame: 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.
4 secondary outcomes
Hair parting test
Time frame: 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).
Videodermatoscopy
Time frame: 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).
Pull test
Time frame: 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).
Sebometry
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bioscalin® new formulation with Galeopsis Segetum and Reference product in people with Telogen Effluvium, run by Derming SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of the percentage of hair in anagen phase (time frame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.