VitiligoPhase 4NCT04775979
Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo
A Phase 4 study testing diphenylcyclopropenone (DPCP) in people with Vitiligo, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the present work is to evaluate the efficacy and safety of diphenylcyclopropenone (DPCP) as a depigmenting therapy in extensive Vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- diphenylcyclopropenone (DPCP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2021to 30 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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) .
- Conditions
- Vitiligo
- Being tested
- diphenylcyclopropenone (DPCP)
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diphenylcyclopropenone (DPCP)Drug
Depigmenting agent
| Study group | Role | What they receive |
|---|---|---|
| Diphenylcyclopropenone (DPCP) | Experimental | Applying DPCP topically Receives: Drug: diphenylcyclopropenone (DPCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start17 Jan 2021
- Primary completion30 Jul 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayson, Ain Shams University
- Investigators
- Marwa MA Abdallah, Study chair, Ain Shams UniversityRania M Elhusseiny, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775979
- Sponsor's protocol ID
- FMASUMS730/2020/2021
- Status last verified
- Apr 2023
- First submitted
- 20 Feb 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo
- ClinicalTrials.gov ID
- NCT04775979
- Acronym / sponsor ID
- FMASUMS730/2020/2021
- Conditions
- Vitiligo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diphenylcyclopropenone (DPCP) | Experimental | Drug: diphenylcyclopropenone (DPCP)Applying DPCP topically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diphenylcyclopropenone (DPCP)Depigmenting agent | Drug | Diphenylcyclopropenone (DPCP) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa MA Abdallah study chair
Ain Shams University
Rania M Elhusseiny study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing diphenylcyclopropenone (DPCP) in people with Vitiligo, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depigmentation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.