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Treatment of Keratosis Pilaris With 810 nm Diode Laser

NCT ID: NCT01281644

Last Updated: 2021-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-10-31

Brief Summary

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The investigators hope to establish whether or not the diode laser, a longer-wavelength laser, is effective in treating keratosis pilaris, and hopefully opening a door into the discussion and management of this skin condition. The primary outcome of interest is the difference in the overall blind rater severity scores of the treated versus the untreated sites. The secondary outcome of interest is the change in the patient's self-rated severity score of the treated site. To account for potential natural disease progression or regression, the investigators will also compare patient mean changes to the mean changes in severity scores of the untreated site.

Detailed Description

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Conditions

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Keratosis Pilaris (KP)

Keywords

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Keratosis pilaris (KP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No Laser Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

45-60 J Diode Laser Therapy

Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.

Group Type ACTIVE_COMPARATOR

Diode Laser

Intervention Type DEVICE

810 nm diode laser

Interventions

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Diode Laser

810 nm diode laser

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is age 18 to 65
* Subject has diagnosis of keratosis pilaris involving both arms
* Subject has Fitzpatrick Skin Type I - III
* Subject is in good health
* Subject has the willingness and ability to understand and provide informed consen

Exclusion Criteria

* Under 18 or over 65 years of age
* Subjects with Fitzpatrick Skin Type greater than III
* Subjects who have received any laser therapy to the armsin the past year
* Subjects with concurrent diagnosis of another skin condition or malignancy
* Subjects with tan or sunburn over the upper arms in the past month
* Subjects with open, non-healing sores or infections at any skin site
* Subjects who are unable to understand the protocol or give informed consent
* Subjects who take oral photosensitizing medications or who apply topical photosensitizing medications to either arm
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Associate Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Ibrahim O, Khan M, Bolotin D, Dubina M, Nodzenski M, Disphanurat W, Kakar R, Yoo S, Whiting D, West DP, Poon E, Veledar E, Alam M. Treatment of keratosis pilaris with 810-nm diode laser: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):187-91. doi: 10.1001/jamadermatol.2014.2211.

Reference Type DERIVED
PMID: 25372313 (View on PubMed)

Other Identifiers

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MA111810

Identifier Type: -

Identifier Source: org_study_id