Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dermatitis Herpetiformis
Intervention: Dapsone gel, 5% (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Vanderbilt University Overall contact: Mary Beth Cole, MD, Phone: 615-936-1133, Email: marybeth.cole@vanderbilt.edu
Summary
The primary objective of this study is to evaluate the efficacy of dapsone gel, 5% in the
treatment of dermatitis herpetiformis. The primary efficacy end point will be the
proportion of patients achieving success based on mean % reduction from baseline in total
lesion counts at week six. Success for lesion reduction will be defined as statistically
greater mean percent reductions at week six in the dapsone gel-treated extremity compared
with the control extremity of each patient.
Clinical Details
Official title: Dapsone Gel, 5% for Topical Treatment of Dermatitis Herpetiformis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number and size of all lesions on the treated and untreated elbows or knees of patients with dermatitis herpetiformis who have one extremity treated with Dapsone gel, 5%
Secondary outcome: Number of papules, plaques and vesicles on treated and untreated elbows or knees of patients who have one extremity treated with Dapsone gel, 5%Evaluation of clinical photographs and scoring of photographs based on a modified Global Acne Assessment Score
Detailed description:
The study will be a prospective evaluation of dapsone gel, 5% in patients with a clinical
diagnosis of dermatitis herpetiformis. Active disease must occur on the patients' bilateral
elbows or bilateral knees at the time of study enrollment. Active disease will be defined
as five or more papules/pustules/vesicles on an extremity. Randomization of one of the
patient's extremities (either one elbow or one knee) to the treatment group will occur at
time of enrollment. Randomization will be in the sequence of right side assigned to odd
numbered patients and left side assigned to even numbered patients. Thus, the first patient
to be enrolled, patient number one, would be randomized to treatment on his or her right
side. Depending on the site of active disease, he or she would apply topical dapsone gel,
5% to the right elbow or knee twice daily for the duration of the study.
No blinding of the patients or the PI will occur. The co-investigator will be blinded to
whether the photographs presented to him at the end of the study are those of a treated or
untreated extremity.
The patients will be screened for study enrollment in a private clinic room within the
dermatology clinic at One Hundred Oaks. Patients will be presented with a study summary
sheet and a consent form. They will be allowed to ask questions pertaining to the study
protocol. Information provided to them will be that found in the study protocol alone. If
desired, informed consent can be taken home with the patient to consider, and enrollment can
be performed at a later date. In that instance, the patient would be brought back for an
additional visit at the time of consent and study enrollment. Study enrollment and first
treatment will be performed on the day of study consent. Digital photographs of each elbow
or each knee (treatment and control) will be taken on the day of enrollment to serve as a
baseline evaluation. The number of lesions (including papules, plaques and vesicles) will
be recorded for the treatment and control elbow or knee. Measurements of each lesion will
be taken and recorded as well. This data will be written in a chart and stored in the PI's
notebook in a locked cabinet in the department of dermatology. Digital photographs will be
printed out on the same day as the visit and placed in the notebook as well. Two copies of
each photograph will be made. Each photograph will be assigned a letter, A through Z, based
on a code for each patient. One copy of each set of photographs will also include the date.
No patient identifiable features will be included in the photograph such as the face or
eyes. Each photograph will be of the treated or control area only. The code to identify
patient photographs will be assigned by the Data and Safety Monitor and kept in a separate
locked cabinet. The code will be broken following the blinded evaluation of the photographs
by co-investigator.
The patient will be given oral instructions regarding the application of topical dapsone
gel, 5% by the PI on the day of enrollment. The PI will apply the first treatment to the
randomized extremity during the first clinic visit. The patient will then remain in the
treatment room for fifteen minutes to evaluate for any immediate adverse reaction. The PI
will remain in the room with the patient. At the end of the fifteen minute evaluation, the
patient will be sent home with written instructions for application and a 30gm tube of
ACZONE™ (dapsone) Gel, 5%. Patients will apply the study drug to the indicated elbow or
knee each morning and evening for the two weeks. They will return to the dermatology clinic
in two weeks and be seen in a private clinic room by the PI for a follow up visit. At that
time, photographs, lesion counts and measurements will be taken again, just as they were at
the initial visit. The patient will be asked to report any adverse events at that time.
Patients will be instructed to continue treatment and follow up in two weeks. The same
parameters will be evaluated at the four week visit and again at the six week visit, which
will be the completion of the study.
Patients will discontinue treatment after six weeks. The co-investigator will be presented
will all photograph marked with the patient letter only. He will not know the sequence of
the photographs or dates taken. He will then assign a number according to his subjective
evaluation of the clinical photographs, while also being blinded to which elbow or knee was
treated, right or left. The scores assigned will follow the criteria listed in the
investigator's Dermatitis Herpetiformis Assessment Score. The code to the photographs will
be broken after the completion of photograph evaluation. Photographs of a set will be
matched to those with both letter and date to determine the scores in chronological order.
Six weeks after completion of treatment each patient will be contacted by phone and asked a
series of five questions. That will conclude the study.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 12 years or older
- Clinical diagnosis of dermatitis herpetiformis, as previously diagnosed by the
patient's primary dermatologist or diagnosed by agreement of the two investigators
- Active disease at time of enrollment, defined as at least five inflammatory lesions
(to include papules, plaques and vesicles) on the bilateral elbows or bilateral knees
Exclusion Criteria:
- Patients taking oral dapsone or those who have taken oral dapsone within four weeks
prior to enrollment
- Patients using any other topical treatment for dermatitis herpetiformis at time of
enrollment or within the four weeks prior to enrollment
- Patients with known allergy or hypersensitivity to dapsone, sulfa drugs or excipients
of the dapsone gel product
- Women will be excluded if pregnant or nursing
- Women of childbearing potential must be practicing an effective method of birth
control as determined by the enrolling physician. If oral contraceptives are the
method of choice, then the patient must have been on a stable dose for a minimum of 3
months. (This is the same guideline used for women of childbearing potential in
previous studies of acne patients.)
Locations and Contacts
Mary Beth Cole, MD, Phone: 615-936-1133, Email: marybeth.cole@vanderbilt.edu
Vanderbilt University - One Hundred Oaks, Nashville, Tennessee 37204, United States; Not yet recruiting Mary Beth Cole, MD, Principal Investigator
Additional Information
Starting date: July 2010
Last updated: April 29, 2010
|