Topical Cetirizine in Treatment of Localized Alopecia Areata

NCT05803070 | Unknown

• 1 other identifier: Alopecia areata treatment
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate and compare the efficacy and safety of topical cetirizine 1%, versus topical betamethasone valerate 0.1% in the treatment of localized alopecia areata.

Conditions

Alopecia Areata

Keywords

Cetirizine

Outcome Measures

Primary Outcomes (4)

• Compare topical cetirizine and betamethasone valerate in treatment of alopecia areata

  compare the healing rate

  baseline

• Clinical evaluation by SALT score

  an ideal objective method of follow-up and good evaluation of any therapeutic option

  baseline

• Clinical evaluation by photographic evaluation

  The photographs and response to treatment will be evaluated objectively by two-blinded dermatologists using a five-point semiquantitative score (regrowth scale) defined as follows: 0 score (regrowth \<10%), 1 score (regrowth 11-25%), 2 score (regrowth 26-50%), 3 score (regrowth 51-75%), 4 score (≥ 75)

  baseline

• Clinical evaluation by patient's satisfaction level

  Asking the patients about their satisfaction towards treatment using a five-point scale (-1: condition worsened, 0: not satisfied, 1: poorly satisfied, 2: moderately satisfied, 3: very satisfied)

  baseline

Study Arms (2)

A

patients with alopecia areata who will be treated with topical cetirizine 1%

Drug: Topical Cetirizine 1 %

B

patients with alopecia areata who will be treated with topical betamethasone valerate 0.1%

Drug: Topical betamethasone valerate 0.1%

Interventions

Topical Cetirizine 1 % DRUG

topical cetirizine belongs to anti histamines group

A

Topical betamethasone valerate 0.1% DRUG

topical betamethasone valerate belongs to corticosteroids group

B

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with alopecia areata who attend the outpatient clinic of Dematology department ,Assuit University hospital.

You may qualify if:

• Participants of both sex with age ≥ 12 years.
• Localized alopecia areata: \<50% affection of the scalp surface.
• Stable disease (no new patches or increase in size for at least 2 weeks)

You may not qualify if:

• Uncertain diagnosis.
• Age \< 12 years.
• Severe forms of alopecia (extensive alopecia; \> 50% of scalp surface), ophiasis type, alopecia totalis or alopecia universalis.
• Alopecia Areata outside the scalp.
• Patients who have received topical treatment for alopecia areata in the past month.
• Patients who have received systemic treatment for alopecia areata in the past 2 months.
• Any associated skin or hair disorders.
• Any associated medical condition requiring oral corticosteroids, immunosuppressive or light therapy.
• Presence of any systemic autoimmune disease.
• Pregnant and lactating women
• Unrealistic expectations.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Rossi A, Campo D, Fortuna MC, Garelli V, Pranteda G, De Vita G, Sorriso-Valvo L, Di Nunno D, Carlesimo M. A preliminary study on topical cetirizine in the therapeutic management of androgenetic alopecia. J Dermatolog Treat. 2018 Mar;29(2):149-151. doi: 10.1080/09546634.2017.1341610. Epub 2017 Jun 29.

  PMID: 28604133 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mariam Esam Fathy, master

CONTACT

01226593916; mariamessam22112018@gmail.com

Marwa Mohamed Abdelhakim

CONTACT

01004899436; marwamekkawy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 7, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-03