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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03273504
• Date of registration: 04/09/2017
• Prospective Registration: No
• Primary sponsor: Derming SRL
• Public title: Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
• Scientific title: Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
• Date of first enrolment: July 14, 2017
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03273504
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Hypertrichosis

Intervention(s)

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

Other: Placebo

Primary Outcome(s)

Change from baseline of hair regrowth speed [Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)]

Change from baseline of the percentage of terminal hair [Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)]

Change from baseline of the percentage of vellus hair [Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)]

Change from baseline of the hair density [Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)]

Secondary Outcome(s)

Change from baseline of superficial skin hydration [Time Frame: Baseline (T0), 1 month (T1), 3 months (T3)]

Secondary ID(s)

E1517

Source(s) of Monetary Support

Please refer to primary and secondary sponsors