Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003334544 Date of Approval: 18/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title TCA 35% versus phenol 88% in treatment of alopecia areata
Official scientific title A randomized controlled trial of TCA 35% versus phenol 88% in treatment of alopecia areata
Brief summary describing the background and objectives of the trial Alopecia areata (AA) is a common, non-scarring form of hair loss caused by immune-mediated attack of the hair follicle. As with other immune-mediated diseases, a complex interplay between environment and genetics is thought to lead to the development of AA (Thompson, et al., 2017). Many treatment options for AA are used, however, there is no universally proven therapy that induces and maintains remission of the condition (Hordinsky and Donati, 2014). Among topical immunotherapeutic agents, phenol & Trichloroacetic acid (TCA) are papillary dermis peels that act via therapeutic wounding. Phenol (carbolic acid) is a contact irritant, that can be used in the treatment of AA (Kar et al., 2013), especially in children who fear the intralesional injections. (Savant et al., 1999). It acts by way of "antigenic competition" and immunomodulation thereby decreasing the immune attack on pigmented anagen hairs (Chikhalkar et al., 2013). It also releases various growth factors during the wound repair process that stimulate the hair follicles. Moreover, cytokines released during wound healing neutralize the peribulbar infiltrates, causing re-growth of hair. Lastly, it is proposed that phenol passes through the follicular opening and directly stimulates the germinal center (Kar et al., 2013). TCA is an extremely versatile peel that can reach all depths and can be applied to all skin types, on all parts of the body and in many indications (Deprez, 2016). When applied to the skin, TCA causes coagulation of epidermal and dermal proteins, and necrosis of collagen up to the upper reticular dermis (Lee et al., 2002). It has been shown that some specific growth factors including platelet derived growth factor (PDGF), as well as various inflammatory cytokines, are transiently produced by TCA-treated keratinocytes before their necrosis (Yonei et al., 2007). Objective: To evaluate the efficacy, safety, and tolerability of TCA 35% peel in comparison to phenol peel 88% in AA treatment
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Alopecia areata,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2017
Actual trial start date 01/08/2017
Anticipated date of last follow up 01/05/2018
Actual Last follow-up date 01/05/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation using coin-tossing Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TCA 35% every 3 weeks 3 consecutive months applying TCA 35% on one of the alopecia areata patches 20
Experimental Group Phenol 88% every 3 weeks 3 consecutive months applying phenol 88% on one of the alopecia areata patches 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects with multifocal patchy AA of the scalp (> 2 patches). Both genders. Age group > 4 years old. Any subject with any variant of AA other than the multifocal patchy variant. Any subject with end-stage cicatrized AA. Any subject who is currently experiencing significant spontaneous regrowth of terminal hair. Any subject treated with a topical, intralesional or systemic agent likely to cause regrowth in AA within one month prior to enrollment in the study. Any subject with a dermatological condition affecting the scalp other than AA: e.g. psoriasis, eczema. Any subject with psychiatric illness or psychological state interfering with compliance or influencing the expectation of the patient. 4 Year(s) 60 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 12/07/2017 Derma REC
Ethics Committee Address
Street address City Postal code Country
Manial Cairo 11531 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy of TCA 35% and phenol 88% in the treatment of alopecia areata after 3 months after 9 months
Secondary Outcome tolerability of TCA 35% and phenol 88% in alopecia areata treatment every 3 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dermatology department, Cairo University Manial Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor no sponsor Hospital
COLLABORATORS
Name Street address City Postal code Country
Dina Saadi Kasr AlAiny Cairo 11553 Egypt
Riham Mohye Eldeen Kasr AlAiny Cairo 11553 Egypt
Doaa Mahgoub Kasr AlAiny Cairo 11553 Egypt
Sarah Ibrahim Kasr AlAiny Cairo 11553 Egypt
Solwan ElSamadouny Kasr AlAiny Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa Mahgoub doaamahgoub@hotmail.com +201005670009 Kasr AlAiny
City Postal code Country Position/Affiliation
Cairo 11531 Egypt Professor of Dermatology / Cairo university
Role Name Email Phone Street address
Public Enquiries Riham Mohye Eldin dr.rm.sc@gmail.com +20106239360 Kasr AlAiny
City Postal code Country Position/Affiliation
Cairo 11531 Egypt Resident of Dermatology / Cairo University
Role Name Email Phone Street address
Scientific Enquiries Dina Saadi dina.saadi@hotmail.com +2-1222442771 Kasr AlAiny
City Postal code Country Position/Affiliation
Cairo 11531 Egypt Lecturer of Dermatology / Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information