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Completed

NCT Number: NCT03273504

Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo

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)

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Key information

Conditions

Hypertrichosis Hair Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DERMING

Milan, MI, 20149, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • systemic corticosteroids
  • aspirin or non-steroid anti-inflammatory drugs (FANS)
  • diuretic.

Treatment and study plan

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.

Placebo

Other

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. Change from baseline of superficial skin hydration

    Time frame: Baseline (T0), 1 month (T1), 3 months (T3)

    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.

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 6, 2017
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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