Clinical Investigation of Safety and Effectiveness of Emerald IPLdevice (NCT03945383) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of Safety and Effectiveness of Emerald IPLdevice
United States120 participantsStarted 2019-04-15
Plain-language summary
Prospective, multi-center, single-arm, single blinded (Philips hair counter) study in healthy women of skin types I up to and including V.
Safety and efficacy of hair removal with the Emerald IPL-device will be investigated for treatment in face of subjects with ST I - IV and for treatment in face, axilla, bikini area, and legs of subjects with ST V.
In-clinic, the study subjects will undergo twelve IPL-treatments bilaterally at the qualified areas (face and / or axilla, bikini line, and legs) with the Emerald IPL device applied by a device operator.
Hair re-growth in each area will be evaluated separately and across all skin types.
After the 4 bi-weekly treatments, one follow-up visit will be organized two weeks after the 4th treatment. After the completion of the full treatment cycle (12 treatments), subjects will be followed for 1 and 3 months (short-term follow-up) and for 6, 9 and 12 months (long-term follow up).
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Be willing to provide informed consent
✓. Are healthy female subjects, in age of 18-65 years
✓. Have natural body hair color that is dark blonde, brown or black in the designated treatment areas
✓.1. Subjects of ST I-IV - Face group:
✓.1.1 Have Fitzpatrick Skin Type I, II, III, or IV
✓.1.2 Measure melanin value ≤ 375 in the qualifying treatment areas bilateral on upper lip (face)
✓.1.3. Have a minimum of 10 hairs in the 1x2cm2 qualifying treatment areas bilateral on upper lip (face), by visual inspection
✓.2. Subjects of ST V - All body area group:
Exclusion criteria
✕. Have natural body hair color that is white, light blond, or red in the designated treatment areas
✕.1. Subjects of ST I to IV - Face group:
What they're measuring
1
Proportion of subjects with at least 30% hair reduction relative to baseline at 8 and 10 weeks after baseline and at 1 and 3 months after last treatment