HypertrichosisNCT03273504
Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
A study testing Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) in people with Hypertrichosis, run by Derming SRL at 1 site in Italy.
Trial summary
Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects) Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrichosis
- What is being tested?
- Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jul 2017to 30 Oct 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
- female sex
- with hypertrichosis
- agreeing not to perform epilation or scrub/peeling treatment on the test area (legs) during the week preceding the inclusion
- good general state of health
Who cannot join
- pregnancy
- lactation
- subjects whose insufficient adhesion to the study protocol is foreseeable
- sensitive skin
- oral contraceptive therapy started less than 1 year
- presence of varicose or capillary veins of surface
Show all 18Show fewer
- hormonal therapies able to influence hair growth.
- presence of cutaneous disease on the tested area, as lesions, scars, malformations.
- diabetes
- endocrine disease
- hepatic disorder
- renal disorder
- cardiac disorder
- cancer.
- farmacological topical treatment and surgery and/or medical treatment on the treated side performed in the last 3 months
- systemic corticosteroids
- aspirin or non-steroid anti-inflammatory drugs (FANS)
- diuretic.
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects)
- Conditions
- Hypertrichosis
- Being tested
- Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy), Placebo
- Medical subject headings
- Hypertrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)Other
The study product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the right or left leg (tibialis area) according to a randomisation list.
PlaceboOther
The placebo product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the controlateral leg (tibialis area) right or left leg according to a randomisation list.
| Study group | Role | What they receive |
|---|---|---|
| Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) | Experimental | Comparison within subjects of Actapil Corpo Spray versus Placebo. The study product will be applied twice a dayon the right or left leg (tibialis area) according to a randomisation list.
The placebo product will be applied in the same way, on the controlateral leg. Receives: Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the hair density
Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Measured: Baseline (T0), 1 month (T1), 3 months (T3)
Change from baseline of the percentage of terminal hair
Percentage of terminal hair (terminal hair has a diameter >0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Measured: Baseline (T0), 1 month (T1), 3 months (T3)
Change from baseline of the percentage of vellus hair
Percentage of vellus hair (terminal hair has a diameter <0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Measured: Baseline (T0), 1 month (T1), 3 months (T3)
Change from baseline of hair regrowth speed
Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Measured: Baseline (T0), 1 month (T1), 3 months (T3)
Secondary outcomes (1)
Change from baseline of superficial skin hydration
Skin electrical capacitance value is measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany).
The measure of the skin capacitance properties is an indirect expression of its hydration level.
Measured: Baseline (T0), 1 month (T1), 3 months (T3)
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 start14 Jul 2017
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrichosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT03273504
- Sponsor's protocol ID
- E1517
- Status last verified
- Jan 2018
- First submitted
- 4 Sep 2017
- Last updated
- 9 Jan 2018
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
- ClinicalTrials.gov ID
- NCT03273504
- Acronym / sponsor ID
- E1517
- Conditions
- Hypertrichosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 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.
Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) | Experimental | Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy), Other: PlaceboComparison within subjects of Actapil Corpo Spray versus Placebo. The study product will be applied twice a dayon the right or left leg (tibialis area) according to a randomisation list. The placebo product will be applied in the same way, on the controlateral leg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy volunteers
- female sex
- with hypertrichosis
- agreeing not to perform epilation or scrub/peeling treatment on the test area (legs) during the week preceding the inclusion
- good general state of health
Key exclusion criteria (18 listed)
- pregnancy
- lactation
- subjects whose insufficient adhesion to the study protocol is foreseeable
- sensitive skin
- oral contraceptive therapy started less than 1 year
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 |
|---|---|---|
| Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)The study product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the right or left leg (tibialis area) according to a randomisation list. | Other | Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) |
| PlaceboThe placebo product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the controlateral leg (tibialis area) right or left leg according to a randomisation list. | Other | Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) |
Primary outcome
Change from baseline of the hair density
Time frame: Baseline (T0), 1 month (T1), 3 months (T3)
Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Change from baseline of the percentage of terminal hair
Time frame: Baseline (T0), 1 month (T1), 3 months (T3)
Percentage of terminal hair (terminal hair has a diameter >0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Change from baseline of the percentage of vellus hair
Time frame: Baseline (T0), 1 month (T1), 3 months (T3)
Percentage of vellus hair (terminal hair has a diameter <0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Change from baseline of hair regrowth speed
Time frame: Baseline (T0), 1 month (T1), 3 months (T3)
Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
1 secondary outcome
Change from baseline of superficial skin hydration
Time frame: Baseline (T0), 1 month (T1), 3 months (T3)
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 9 Jan 2018.
Related trials for Hypertrichosis
RecruitingObservational study
Treatment of Hypertrichosis With Intense Pulsed Light
Hypertrichosis, Hirsutism - Hypertrichosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) in people with Hypertrichosis, run by Derming SRL at 1 site in Italy.
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 5 inclusion and 18 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 hair density (time frame: Baseline (T0), 1 month (T1), 3 months (T3)). The study lists 4 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 9 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.