NCT00402129

Brief Summary

To report the safety and efficacy of 1064nm low fluence laser hair reduction for the treatment of pseudofolliculitis barbae

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
Last Updated

November 22, 2006

Status Verified

November 1, 2006

First QC Date

November 20, 2006

Last Update Submit

November 20, 2006

Conditions

Pseudofolliculitis Barbae

Keywords

Ethnic SkinLaserPhotobiologyQuality of life

Outcome Measures

Primary Outcomes (1)

  • Reduction of PFB by assessing dyspigmentation, papule counts and cobblestoning.

Secondary Outcomes (1)

  • In addition, hair and papule counts were performed on a subset of five patients.

Interventions

1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.PROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active duty males/females, 18 years of age or older, Fitzpatrick skin types IV to VI, and all presented with a pseudofolliculitis barbae as determined by one of the dermatologists participating in the study

You may not qualify if:

  • history of vitiligo, photosensitivity, keloids, or herpes simplex in the treatment area, or any chronic medical conditions that may impair wound healing, such as diabetes mellitus and collagen vascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Related Publications (14)

  • Alajlan A, Shapiro J, Rivers JK, MacDonald N, Wiggin J, Lui H. Paradoxical hypertrichosis after laser epilation. J Am Acad Dermatol. 2005 Jul;53(1):85-8. doi: 10.1016/j.jaad.2004.06.054.

    PMID: 15965427BACKGROUND

  • Alster TS, Bryan H, Williams CM. Long-pulsed Nd:YAG laser-assisted hair removal in pigmented skin: a clinical and histological evaluation. Arch Dermatol. 2001 Jul;137(7):885-9.

    PMID: 11453807BACKGROUND

  • Bronner AK, Hood AF. Cutaneous complications of chemotherapeutic agents. J Am Acad Dermatol. 1983 Nov;9(5):645-63. doi: 10.1016/s0190-9622(83)70177-5.

    PMID: 6643764BACKGROUND

  • Garcia-Zuazaga J. Pseudofolliculitis barbae: review and update on new treatment modalities. Mil Med. 2003 Jul;168(7):561-4.

    PMID: 12901468BACKGROUND

  • Guardiano RA, Norwood CW. Direct comparison of EMLA versus lidocaine for pain control in Nd:YAG 1,064 nm laser hair removal. Dermatol Surg. 2005 Apr;31(4):396-8. doi: 10.1111/j.1524-4725.2005.31104.

    PMID: 15871313BACKGROUND

  • Lanigan SW. Incidence of side effects after laser hair removal. J Am Acad Dermatol. 2003 Nov;49(5):882-6. doi: 10.1016/s0190-9622(03)02106-6.

    PMID: 14576669BACKGROUND

  • Lim SP, Lanigan SW. A review of the adverse effects of laser hair removal. Lasers Med Sci. 2006 Sep;21(3):121-5. doi: 10.1007/s10103-006-0377-y. Epub 2006 Jul 1.

    PMID: 16816888BACKGROUND

  • Orringer JS, Hammerberg C, Lowe L, Kang S, Johnson TM, Hamilton T, Voorhees JJ, Fisher GJ. The effects of laser-mediated hair removal on immunohistochemical staining properties of hair follicles. J Am Acad Dermatol. 2006 Sep;55(3):402-7. doi: 10.1016/j.jaad.2006.04.057. Epub 2006 May 26.

    PMID: 16908343BACKGROUND

  • Rohrer TE, Chatrath V, Yamauchi P, Lask G. Can patients treat themselves with a small novel light based hair removal system? Lasers Surg Med. 2003;33(1):25-9. doi: 10.1002/lsm.10192.

    PMID: 12866118BACKGROUND

  • Ross EV, Cooke LM, Overstreet KA, Buttolph GD, Blair MA. Treatment of pseudofolliculitis barbae in very dark skin with a long pulse Nd:YAG laser. J Natl Med Assoc. 2002 Oct;94(10):888-93.

    PMID: 12408693BACKGROUND

  • Ross EV, Cooke LM, Timko AL, Overstreet KA, Graham BS, Barnette DJ. Treatment of pseudofolliculitis barbae in skin types IV, V, and VI with a long-pulsed neodymium:yttrium aluminum garnet laser. J Am Acad Dermatol. 2002 Aug;47(2):263-70. doi: 10.1067/mjd.2002.124081.

    PMID: 12140474BACKGROUND

  • Ross EV, Ladin Z, Kreindel M, Dierickx C. Theoretical considerations in laser hair removal. Dermatol Clin. 1999 Apr;17(2):333-55, viii. doi: 10.1016/s0733-8635(05)70091-7.

    PMID: 10327301BACKGROUND

  • Weaver SM 3rd, Sagaral EC. Treatment of pseudofolliculitis barbae using the long-pulse Nd:YAG laser on skin types V and VI. Dermatol Surg. 2003 Dec;29(12):1187-91. doi: 10.1111/j.1524-4725.2003.29387.x.

    PMID: 14725660BACKGROUND

  • Weinstein GD, Mooney KM. Cell proliferation kinetics in the human hair root. J Invest Dermatol. 1980 Jan;74(1):43-6. doi: 10.1111/1523-1747.ep12514601.

    PMID: 7351493BACKGROUND

MeSH Terms

Conditions

pseudofolliculitis barbae

Study Officials

  • E. Victor Ross, MD

    Scripps Green Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

January 1, 2006

Study Completion

May 1, 2006

Last Updated

November 22, 2006

Record last verified: 2006-11

Locations

US(1)