Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo

NCT04775979 | Completed Phase 4

• 1 other identifier: FMASUMS730/2020/2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diphenylcyclopropenone (DPCP)

EXPERIMENTAL

Applying DPCP topically

Drug: diphenylcyclopropenone (DPCP)

Interventions

diphenylcyclopropenone (DPCP) DRUG

Depigmenting agent

Diphenylcyclopropenone (DPCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

University hospitals faculty of medicine ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Interventions

diphenylcyclopropenone

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marwa MA Abdallah

  Ain Shams University

  STUDY CHAIR

• Rania M Elhusseiny

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 1, 2021
• Study Start: January 17, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 30, 2021
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)