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SmoothSkin Pure Ice Clinical Study: IPL with Sapphire Ice Cooling, up to 99% hair reduction in 12 weeks

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Resultados clave

  • Up to 99% hair reduction after 12 weeks (legs, CD3137).
  • Up to 95% hair reduction after just 2 treatments (legs, CD3191).
  • Visible results in 2 weeks (underarms, CD3191).
  • Hair reduction sustained for up to 12 months (CD3028).
  • 97.5% of users found the treatment gentle on their skin.
  • 92.5% found it as painless as shaving.
  • 95% found it gentler than shaving on the underarms.
  • Randomized trials in women aged 18 to 55 with Fitzpatrick skin types I to V.
  • FDA-cleared technology.

Resumen

CSD 045 claims supporting document (version 2, 2025) by CyDen Ltd. compiling evidence from three randomized, open-label, prospective clinical trials on SmoothSkin Pure Ice low-fluence IPL (intense pulsed light) technology in women aged 18 to 55 with Fitzpatrick skin types I to V.

  • CD3191 (40 women, 13 weeks, axillae and legs): efficacy, safety, and tolerability of Pure Ice (with cooling) versus Pure Switch in a split-body design.
  • CD3137 (36 women, 20 weeks, axillae and legs): hair reduction after 12 weekly treatments.
  • CD3028 (50 women, 61 weeks, axillae, groin, and legs): sustained hair reduction at 6, 9, and 12 months. Data submitted to the FDA for device clearance.

Hair reduction was measured by quantitative counting using automated software and independent evaluators.

Desarrollo del estudio

Methodology

  • Design: randomized, controlled, open-label, prospective clinical trials with a split-body design.
  • Population: healthy women aged 18 to 55, Fitzpatrick skin types I to V, with natural brown or black hair in the treated areas.
  • Primary endpoint: quantitative hair count compared to baseline; in CD3191, the occurrence of moderate or severe adverse effects recorded in a diary.
  • Visible outcome criterion: reduction in hair count equal to or greater than 30%.
  • Analysis: full analysis set (FAS) and sensitivity (SEN) population, with consistent results between both.

Results by trial

CD3191: after only 2 treatments, between 55% and 88% of users achieved visible results. Maximum recorded reduction of 95.5% in legs at 2 weeks. Average reduction in leg with Pure Ice of 46.1% to 48.9% compared to 36.4% to 40.9% without cooling.

CD3137: after 12 weeks, the majority of participants achieved a hair reduction equal to or greater than 90% in legs (68.8% in the right leg and 60.0% in the left leg). Some participants achieved 100% reduction.

CD3028: sustained median reduction of 44% at 6 months and 35% at 12 months after the last treatment, statistically significant. Incidence of device-related effects of 3% (18 out of 564 treatments), all mild and expected. Average pain of 10 mm on a 100 mm scale. 93% would recommend the device.

Technology

  • Next-generation IPL: the melanin in the hair absorbs the light and acts on the follicle in the anagen phase; therefore, the protocol lasts 12 weeks.
  • Sapphire Ice Cooling: sapphire crystal that cools the skin before, during, and after each shot.
  • Skin tone sensor: automatically adjusts the energy in each shot. Adjustable energy from 3 to 6 J/cm².
  • Unlimited flashes: no cartridges or replacements.

Protocol

One treatment per week for 12 weeks and, afterwards, monthly maintenance sessions.

Conclusiones

Clinical evidence from CyDen Ltd. demonstrates that SmoothSkin Pure Ice IPL technology achieves up to a 99% reduction in hair in 12 weeks, up to 95% after just 2 treatments, and sustained reduction for up to 12 months.

The Sapphire Ice Cooling system improves tolerability: 97.5% of female users found the treatment gentle on their skin, and 92.5% found it as painless as shaving, with minimal, mild, and transient adverse effects.

Individual results may vary depending on skin tone, hair color, and adherence to the protocol.