Trial no.:	PACTR201808699550182	Date of Approval:	31/08/2018
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Monobenzyl Ether of Hydroquinone in Depigmentation of Vitiligo.

Official scientific title

Monobenzyl Ether of Hydroquinone (MBEH) 20% and 40% Cream in Depigmentation of Vitiligo Patients: Randomized controlled trial.

Brief summary describing the background and objectives of the trial

Background: Depigmentation presents a final alternative for patients with widespread vitiligo, failing to attain satisfactory pigmentation and having a compromised quality of life (QOL). Monobenzyl Ether of Hydroquinone (MBEH) is the most widely used topical preparation for depigmentation but little is known regarding specific features of its utilization. Objective: Evaluating and comparing two concentrations of MBEH cream (20% & 40%) regarding their efficacy, tolerability and effect on patients’ QOL.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Skin and Connective Tissue Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

30/11/2016

Actual trial start date

30/11/2016

Anticipated date of last follow up

30/05/2018

Actual Last follow-up date

30/05/2018

Anticipated target sample size (number of participants)

40

Actual target sample size (number of participants)

40

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using by using procedures such as coin-tossing or dice-rolling	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider,Outcome Assessors,Participants
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using by using procedures such as coin-tossing or dice-rolling	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider,Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Monobenzyl ether of hydroquinone 20 percent	twice daily	12 months	Patients applied cream twice daily and were evaluated biweekly until complete depigmentation or the study end point (at 12 months)	20	Active-Treatment of Control Group
Experimental Group	Monobenzyl ether of hydroquinone 40 percent	twice daily	12 months	Patients applied cream twice daily and were evaluated biweekly until complete depigmentation or the study end point (at 12 months)	20

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
 Age above 12 years, both sexes.  Vitiligo patients with >50% body surface area (BSA) involvement retaining few small areas of normal color on face and/or hands.  Vitiligo patients with <50% BSA involvement who are refractory to treatment and aspire at improving aesthetically on face and/or hands.	 Segmental Vitiligo.  Vitiligo responsive to treatment.  Pregnant or breastfeeding women.  Known allergy to MBEH.  Hepatic or renal diseases.  Concomitant oral corticosteroid or immunosuppressive therapy.	Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	12 Year(s)	80 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

03/03/2016

Derma REC

Ethics Committee Address
Street address	City	Postal code	Country
Kasr Alainy	Cairo	12611	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	compare two concentrations of MBEH, 20% and 40% regarding efficacy, tolerability and side effects	every 2 weeks
Secondary Outcome	observe in detail the changes that pigmented skin in vitiligo patients undergoes until complete depigmentation	every 2 weeks
Secondary Outcome	the effect of treatment on patients QOL	at the end of the study

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Kasr Alainy Cairo University	Kasr Alainy	Cairo		Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Vitiligo unit Dermatology department Cairo university	Kasr Alainy	Cairo		Egypt	Individual

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Medhat El Mofty	medhatelmofty@hotmail.com	+201001406742	Kasr Alainy
City	Postal code	Country	Position/Affiliation
Cairo		Egypt	Professor Cairo university
Role	Name	Email	Phone	Street address
Public Enquiries	Dina Saadi	dina.saadi@hotmail.com	+201222442771	105, Maadi
City	Postal code	Country	Position/Affiliation
Cairo		Egypt	Lecturer Cairo university
Role	Name	Email	Phone	Street address
Scientific Enquiries	Dina Saadi	dina.saadi@hotmail.com	+201222442771	105, Maadi
City	Postal code	Country	Position/Affiliation
Cairo		Egypt	Lecturer Cairo university

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Undecided
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry