Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo

Efficacy and Safety of Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo

The aim of the present work is to evaluate the efficacy and safety of diphenylcyclopropenone (DPCP) as a depigmenting therapy in extensive Vitiligo.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Drug: diphenylcyclopropenone (DPCP)

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) .

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • University hospitals faculty of medicine ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients of both genders ≥ 18 years.
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:

1. Children.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diphenylcyclopropenone (DPCP); Applying DPCP topically	Drug: diphenylcyclopropenone (DPCP); Depigmenting agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Marwa MA Abdallah, Ain Shams University; Study Director: Rania M Elhusseiny, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: FMASUMS730/2020/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No