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Pulsed Dye Laser Treatment of Acne Vulgaris

Information source: Laserklinik Karlsruhe
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Fixed combination of clindamycin 1% + benzoyl peroxide 5% (Drug); Pulsed dye laser (Device)

Phase: N/A

Status: Completed

Sponsored by: Laserklinik Karlsruhe

Official(s) and/or principal investigator(s):
Syrus Karsai, MD, Principal Investigator, Affiliation: Laserklinik Karlsruhe

Summary

The results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne after low-fluence pulsed-dye laser therapy, Orringer et al. were unable to replicate said results in a similar, albeit not identical, study design. More recently published studies failed to resolve the controversy, varying in terms of treatment procedure(s) as well as results. While published results are certainly promising enough to be followed up by independent research, they are insufficient to justify the abdication of methods with proven efficacy. Considering patient treatment ethics and the short 'window of opportunity' for scar prevention when active inflammatory lesions are present, the investigators planned the adjuvant application of the PDL in the present study, providing all patients with the well established and evidentially effective modality of a fixed-combination clindamycin 1%-benzoyl peroxide 5% hydrating gel (C/BPO). The goal of the study was the assessment of the efficacy and safety of a low-fluence PDL treatment in addition to C/BPO in patients with facial inflammatory acne.

Clinical Details

Official title: The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Investigator's Static Global Assessment

Lesions count

Secondary outcome:

Dermatology Life Quality Index

Documentation of side effects

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adolescents and adults with moderate inflammatory acne vulgaris (ISGA degrees 2-4)

- Fitzpatrick skin type I-III

Exclusion Criteria:

- Atopic dermatitis

- Oral antibiotics during the last 4 weeks prior to enrolment

- Oral isotretinoin during the last 52 weeks prior to enrolment

- Oral contraceptives during the last 26 weeks prior to enrolment

- Topical acne therapeutics during the last 4 weeks prior to enrolment

- Diagnosis or anamnestic indication of a regional enteritis, Morbus Crohn or

antibiotics-associated colitis

- Laser surgery interventions within the treatment region during the last 12 weeks

prior to enrolment

- Coagulation anomalies or anticoagulant treatment

- Photo-sensitizing medication (e. g., tetracycline, gold)

- Pregnancy

Locations and Contacts

Laserklinik Karlsruhe, Karlsruhe D-76133, Germany
Additional Information

Starting date: October 2008
Last updated: January 19, 2010

Page last updated: August 23, 2015

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