NCT03273504

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

September 4, 2017

Last Update Submit

January 8, 2018

Conditions

Hypertrichosis

Outcome Measures

Primary Outcomes (4)

  • 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)

    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)

    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)

    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)

    Baseline (T0), 1 month (T1), 3 months (T3)

Secondary Outcomes (1)

  • Change from baseline of superficial skin hydration

    Baseline (T0), 1 month (T1), 3 months (T3)

Study Arms (1)

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.

Other: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)Other: Placebo

Interventions

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.

Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
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.

Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers
  • female sex
  • with hypertrichosis
  • good general state of health

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DERMING

Milan, MI, 20149, Italy

Location

MeSH Terms

Conditions

Hypertrichosis

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist, Principal Investigator

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 6, 2017

Study Start

July 14, 2017

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

IT(1)