CompletedNot Applicable

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

Italy24 participantsStarted 2017-07-14

Plain-language 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)

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline of the hair density

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

Change from baseline of the percentage of terminal hair

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

Change from baseline of the percentage of vellus hair

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

Change from baseline of hair regrowth speed

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

Trial details

NCT IDNCT03273504

SponsorDerming SRL

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-30

View on ClinicalTrials.gov More Hypertrichosis trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline of the hair density

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

Change from baseline of the percentage of terminal hair

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

Change from baseline of the percentage of vellus hair

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

Change from baseline of hair regrowth speed

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