Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
diphenylcyclopropenone (DPCP)
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo
Eligibility Criteria
Inclusion Criteria:
- Adult patients of both genders ≥ 18 years.
- Vitiligo universalis patients with cosmetically unacceptable residual pigmentation.
- Extensive vitiligo vulgaris ≥ 50% body surface area (BSA) involvement with areas recalcitrant to repigmentation on exposed skin with consequent psychological impairment.
Exclusion Criteria:
- Children.
- Early, localized, segmental or any vitiligo case responsive to repigmentation treatment.
- Pregnant and lactating females.
- Patients with history of any malignancy.
- Patients with active infectious or inflammatory dermatoses.
- Patients with a history of hypertrophic scars or keloids.
- Patients suffering from cardiac, hepatic or renal disorders.
Sites / Locations
- University hospitals faculty of medicine ain shams university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diphenylcyclopropenone (DPCP)
Arm Description
Applying DPCP topically
Outcomes
Primary Outcome Measures
Depigmentation
Assessment of depigmentation:
For each treated area, response will be assessed as follows (van Geel et al., 2015):
Digital clinical pictures will be used to evaluate the capacity to induce depigmentation and to assess the percentage of depigmentation per test area.
Treatment results will be subsequently classified according to a grading system from 0 to 6 (0 = no effect, 1 = <25%; 2 = 25-49%; 3= 50-47%; 4= 50-74%; 5=90-99%; 6=100%), corresponding to the grade of depigmentation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04775979
Brief Title
Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo
Official Title
Efficacy and Safety of Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the present work is to evaluate the efficacy and safety of diphenylcyclopropenone (DPCP) as a depigmenting therapy in extensive Vitiligo.
Detailed Description
Depigmentation protocol: (Aghaei et al, 2005)
Substance used: DPCP (FLUKA, Sigma-Aldrich, Saint Louis, MO (Missouri), USA) 98% pure powder.
DPCP will be dissolved in acetone to obtain 2% solution.
DPCP solutions will be kept in dark colored bottles at 4ºC (degree Celsius).
Sequential dilution by acetone to yield 1%, 0.5%, 0.1%, 0.01%, 0.05 and 0.001%.
Sensitization by DPCP concentration 2% will be applied to an area 5×5 cm on the forearm
Two weeks following sensitization, treatment will be started by weekly applications of incremental concentrations of DPCP (between 0.001% and 2%) adjusted according to the patient's reactivity to the contact allergen. The aim will be to maintain mild contact eczema and itch for about 48 hours after application. Patients will be instructed to avoid direct sun exposure of the treated area and not to wash it for 48 hours after each application.
Patient follow-up: Patients will come for sensitization at week 0, then after 2 weeks to look for the allergic response, then weekly to reach the effective dose of DPCP. After reaching the effective dose, patients will come weekly to apply DPCP and to look for depigmentation, record possible side effects for 12 consecutive weeks.
Assessment of depigmentation:
For each treated area, response will be assessed as follows (van Geel et al., 2015):
Digital clinical pictures will be used to evaluate the capacity to induce depigmentation and to assess the percentage of depigmentation per test area.
Treatment results will be subsequently classified according to a grading system from 0 to 6 (0 = no effect, 1 = <25%; 2 = 25-49%; 3= 50-47%; 4= 50-74%; 5=90-99%; 6=100%), corresponding to the grade of depigmentation.
Reporting any side effects: such as pain, erythema, blisters, erosions, hyperpigmentation, scarring, appearance of depigmentation in distant sites and/or systemic manifestations (Venkatesh et al,2018) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diphenylcyclopropenone (DPCP)
Arm Type
Experimental
Arm Description
Applying DPCP topically
Intervention Type
Drug
Intervention Name(s)
diphenylcyclopropenone (DPCP)
Intervention Description
Depigmenting agent
Primary Outcome Measure Information:
Title
Depigmentation
Description
Assessment of depigmentation:
For each treated area, response will be assessed as follows (van Geel et al., 2015):
Digital clinical pictures will be used to evaluate the capacity to induce depigmentation and to assess the percentage of depigmentation per test area.
Treatment results will be subsequently classified according to a grading system from 0 to 6 (0 = no effect, 1 = <25%; 2 = 25-49%; 3= 50-47%; 4= 50-74%; 5=90-99%; 6=100%), corresponding to the grade of depigmentation.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of both genders ≥ 18 years.
Vitiligo universalis patients with cosmetically unacceptable residual pigmentation.
Extensive vitiligo vulgaris ≥ 50% body surface area (BSA) involvement with areas recalcitrant to repigmentation on exposed skin with consequent psychological impairment.
Exclusion Criteria:
Children.
Early, localized, segmental or any vitiligo case responsive to repigmentation treatment.
Pregnant and lactating females.
Patients with history of any malignancy.
Patients with active infectious or inflammatory dermatoses.
Patients with a history of hypertrophic scars or keloids.
Patients suffering from cardiac, hepatic or renal disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa MA Abdallah
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rania M Elhusseiny
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
University hospitals faculty of medicine ain shams university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo
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