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Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment

31. august 2012 oppdatert av: Home Skinovations Ltd.

Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for the Treatment of Mild to Moderate Inflammatory Acne.

This is a clinical research study to determine the ability of the Clear device to treat mild to moderate inflammatory acne, and to determine if the average person is able to use the device properly according to the labeling as describe in the operator manual.

The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in which the subjects will be treating themselves with the Clear device, and 2 follow-up visits to evaluate the results. The clinical result will be assessed by the investigator for improvement in the acne condition. Treatment will be performed on the face of subjects enrolled and who meet the inclusion criteria.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The subjects will be recruited if they are eligible to participate in the study according with the device labeling presented at the doctor's office by printed ads. Subjects will be given information about the Clear device according to its labeling. After reading the information and labeling, it will be the subjects' decision if they understand the device label information and if they want to participate in the study. The investigator will review the inclusion / exclusion criteria with the subjects to ensure eligibility.

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5R3N8
        • SpaMedica

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Presence of mild to moderate acne.
  2. Skin Type I to VI (Fitzpatrick).
  3. Males or females who are 21-65 years old.
  4. Willingness to follow the treatment schedule, post-treatment care and have photographs taken.

Exclusion Criteria:

  1. Pacemaker or internal defibrillator.
  2. Permanent implant in the treated area, such as metal plates and screws or silicon, unless deep enough in the bone.
  3. Skin areas that have been injected with Botox/ Hyaluronic acid /collagen/fat injections or other augmentation methods with bio-material during last 6 months.
  4. Current or history of skin cancer, or any other type of cancer, or pre-malignant moles.
  5. Current severe medical conditions, such as heart and lung disorders.
  6. Pregnant or breastfeeding.
  7. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
  8. History of diseases stimulated by heat, such as recurrent Herpes Simplex (cold sores) in the treatment area, unless treated by following a preventive regime.
  9. Poorly controlled endocrine disorders, such as diabetes or thyroid disorders.
  10. Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosacea.
  11. History of skin disorders, keloids (excessive scarring), abnormal wound healing, as well as very dry and fragile skin.
  12. History of bleeding disorders, or use of anticoagulants in the last 10 days.
  13. Any facial surgery performed within 12 months prior to treatment.
  14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
  15. Received treatment with light, laser, radiofrequency (RF), or other devices in the treated area within 6 months.
  16. Used isotretinoin (Accutane®) within 6 months prior to treatment.
  17. Using of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) 1 week before and after each treatment session.
  18. Subjects that are currently or have recently been treated with Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.
  19. Subjects that have been on a steroid regimen within the past 3 months.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: lession count reduction post treatment
  • A total of 50 subjects were included.
  • The majority are female (62 %)
  • At baseline the average number of lesions was 20.5±7.1, ranging from 6 to 36 lesions.
  • All subjects demonstrated a reduction in lesion count.
  • The average improvement after one month was 56.7%±8.9%, and remained similar also after 3 months 57.7%±9.4%.
  • The percent of responders (with at least 40% of reduction) was 94% after 1 month and 96% after 3 months
  • The Percent of responders is similar for males & females and similar for cheeks & front.
Enhet: light based device for treatment of acne

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acne lession count
Tidsramme: 3 months post treatment
acne count post treatment compared to based line count
3 months post treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Home Skinovations Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2011

Primær fullføring (Faktiske)

1. april 2012

Studiet fullført (Faktiske)

1. april 2012

Datoer for studieregistrering

Først innsendt

31. august 2012

Først innsendt som oppfylte QC-kriteriene

31. august 2012

Først lagt ut (Anslag)

5. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. september 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2012

Sist bekreftet

1. august 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C1

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