Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo
NCT ID: NCT04775979
Last Updated: 2023-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2021-01-17
2021-08-30
Brief Summary
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Detailed Description
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* 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) .
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Diphenylcyclopropenone (DPCP)
Applying DPCP topically
diphenylcyclopropenone (DPCP)
Depigmenting agent
Interventions
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diphenylcyclopropenone (DPCP)
Depigmenting agent
Eligibility Criteria
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Inclusion Criteria
2. Vitiligo universalis patients with cosmetically unacceptable residual pigmentation.
3. Extensive vitiligo vulgaris ≥ 50% body surface area (BSA) involvement with areas recalcitrant to repigmentation on exposed skin with consequent psychological impairment.
Exclusion Criteria
2. Early, localized, segmental or any vitiligo case responsive to repigmentation treatment.
3. Pregnant and lactating females.
4. Patients with history of any malignancy.
5. Patients with active infectious or inflammatory dermatoses.
6. Patients with a history of hypertrophic scars or keloids.
7. Patients suffering from cardiac, hepatic or renal disorders.
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mayson
Resident
Principal Investigators
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Marwa MA Abdallah
Role: STUDY_CHAIR
Ain Shams University
Rania M Elhusseiny
Role: STUDY_DIRECTOR
Ain Shams University
Locations
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University hospitals faculty of medicine ain shams university
Cairo, , Egypt
Countries
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Other Identifiers
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FMASUMS730/2020/2021
Identifier Type: -
Identifier Source: org_study_id
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