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SmoothSkin Pure Mini Lite Clinical Study: Low-fluence IPL, up to 92% hair reduction in 4 weeks

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Resultados clave

  • Up to 92% reduction in hair after 4 weeks of treatment.
  • Visible results from 4 weeks with a weekly treatment.
  • Average hair reduction on the leg of 38% to 41% after 4 treatments.
  • 79% of participants rated the treatment positively.
  • Three clinical trials approved by an Independent Ethics Committee (CD3069, CD3070, CD3090).
  • In accordance with the Declaration of Helsinki, GCP and ISO 14155.
  • Clinically tested on skin types I to V.

Resumen

CSD 033 (2023) claims supporting document for CyDen Ltd.’s SmoothSkin Pure Mini Lite. The device has the same energy output as SmoothSkin Bare, so its efficacy is supported by clinical trials conducted with this technology.

  • CD3069: randomized, controlled, comparative, prospective clinical trial on the efficacy, safety, and tolerability of low-fluence IPL devices for home use.
  • CD3070: randomized, controlled, prospective trial on facial IPL hair removal in Fitzpatrick skin types I to V.
  • CD3090: randomized, comparative, prospective trial on underarm hair removal.

Efficacy was measured by quantifying hair counts compared to each participant’s baseline using automated software.

Desarrollo del estudio

Methodology

  • Ethical and regulatory framework: protocols approved by an Independent Ethics Committee, in accordance with the Declaration of Helsinki, ICH Good Clinical Practice (GCP) guidelines, and ISO 14155 standard.
  • Primary endpoint: quantitative hair count at predetermined time points in the trial, expressed as a percentage of the baseline value.
  • Secondary endpoint: self-assessment questionnaires on hair reduction and regrowth, skin texture, and satisfaction.
  • Leg design (CD3069): two areas per leg assigned according to predetermined randomization, with 12 weekly treatments and two maintenance schedules (monthly and bimonthly).

Results

At visit 6 (after the fourth treatment), the mean reduction in leg hair was 38% to 41%, a visible reduction in regrowth. 10% of participants with the best response achieved a mean reduction of 93%, which supports the claim of up to 92% reduction in 4 weeks. Some participants reached 100%. 79% of participants who left comments rated the treatment positively.

Technology

  • Low-fluence IPL: a single energy mode of up to 3 J/cm², designed for home use.
  • Skin tone sensor: automatic energy adjustment for safe treatment.
  • UV filter: protects the skin from unwanted light. Dermatologically tested.
  • Unlimited flashes: no cartridges or replacements.

Protocol

One treatment per week in the area; visible results from 4 weeks. Complete 12-week protocol because hair only responds in the anagen phase.

Conclusiones

CyDen Ltd. clinical trials demonstrate that SmoothSkin Pure Mini Lite's low-fluence IPL technology produces a visible reduction in hair from 4 weeks with weekly treatment, with results of up to 92% reduction in the best-responding participants.

The trials were conducted under the approval of an Independent Ethics Committee and in accordance with the Declaration of Helsinki, GCP and ISO 14155, confirming their efficacy, safety and tolerability for at-home use. Individual results may vary depending on skin tone, hair color and protocol adherence.