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Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo

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ClinicalTrials.gov Identifier: NCT04775979
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Mayson, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vitiligo Drug: diphenylcyclopropenone (DPCP) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo
Actual Study Start Date : January 17, 2021
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diphenylcyclopropenone (DPCP)
Applying DPCP topically
 Drug: diphenylcyclopropenone (DPCP)
Depigmenting agent


Outcome Measures
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Primary Outcome Measures :
  1. Depigmentation [ Time Frame: 6 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775979


Contacts
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Contact: Maysoon Asem 01288335225 mayssoonaassem@gmail.com

Locations
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Egypt
University hospitals faculty of medicine ain shams university Recruiting
Cairo, Egypt
Contact: Faculty of medicine Ain Shams University         
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Marwa MA Abdallah Ain Shams University
Study Director: Rania M Elhusseiny Ain Shams University
More Information
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Responsible Party: Mayson, Resident, Ain Shams University
ClinicalTrials.gov Identifier: NCT04775979    
Other Study ID Numbers: FMASUMS730/2020/2021
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases