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Infrared Non-Cutting Laser Therapy for Acne

30. april 2015 oppdatert av: Jeffrey S. Orringer, University of Michigan

CoolTouch Non-ablative Laser Therapy for Acne Vulgaris

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.

Studieoversikt

Status

Fullført

Forhold

Acne vulgaris

Intervensjon / Behandling

Enhet: CoolTouch II laser

Detaljert beskrivelse

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.

Studietype

Intervensjonell

Registrering

Fase

Fase 2
Fase 3

Kontakter og plasseringer

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

Studiesteder

Forente stater
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48109-0314
    - University of Michigan Dermatology Department

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

13 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Age 13 years or older of either gender and of any racial/ethnic group.
Subjects must have clinically evident acne vulgaris of the facial skin.
Subjects must understand and sign the informed consent prior to participation.
Subjects must be in generally good health.
Subjects must be able and willing to comply with the requirements of the protocol.
You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

Oral retinoid (Accutane) use within 1 year of entry into the study.
Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study.
Microdermabrasion or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
Non-compliant subjects.
Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
Subjects using alcohol-based topical solutions or "exfolliating" agents within 2 weeks of entry into the study.
Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
History of keloid scar formation for subjects undergoing biopsies.
Pregnant or nursing females.

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

Hva måler studien?

Primære resultatmål

Resultatmål
Number of subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones

Sekundære resultatmål

Resultatmål
total area of sebum droplets measured using image analysis software

Samarbeidspartnere og etterforskere

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

Sponsor

University of Michigan

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. februar 2003

Studiet fullført

1. desember 2005

Datoer for studieregistrering

Først innsendt

11. mai 2005

Først innsendt som oppfylte QC-kriteriene