Alopecia AreataNCT05803070
Topical Cetirizine in Treatment of Localized Alopecia Areata
An observational study of Alopecia Areata, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Topical Cetirizine 1 % and Topical betamethasone valerate 0.1%
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Oct 2024
- Phase
- Observational
- 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 12 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: patients with alopecia areata who attend the outpatient clinic of Dematology department ,Assuit University hospital.
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Topical Cetirizine Versus Topical Betamethasone in Treatment of Localized Alopecia Areata
Evaluate and compare the efficacy and safety of topical cetirizine 1%, versus topical betamethasone valerate 0.1% in the treatment of localized alopecia areata.
Read the detailed description
Alopecia areata (AA) is one of the commonest autoimmune non-cicatricial hair loss that affects different parts of hair-bearing areas of the body . Nearly 2% of the population at some stage of their life may be affected by alopecia areata while the prevalence of alopecia areata was reported to be between 0.1% to 0.2%. Alopecia areata can occur at any age, although it starts in the first three decades of life in most patients, and both sexes are equally affected. It can present clinically as a well-defined patch of hair loss, diffuse hair loss, reticulate hair loss, ophiasis, ophiasis inversus, alopecia totalis (complete loss of scalp hair), or alopecia universalis (hair loss of all over the body).
Many treatment options including topical, systemic, injectable and laser modalities have been used for the treatment of AA . Among the various treatment options for alopecia areata, topical corticosteroids as betamethasone valerate are considered as standard therapy.
There have been reports on the efficacy/adjunctive role of systemic antihistamines in alopecia areata. Moreover, fexofenadine was found to enhance hair regrowth in two cases of extensive resistant alopecia areata.
Cetirizine hydrochloride belongs to a family of medicines called antihistamines which has varied medical uses and is commonly used to relieve allergy symptoms such as watery eyes, runny nose, sneezing, hives, and itching. In addition, it has been demonstrated that cetirizine inhibits release of prostaglandin D2 and stimulates the release of prostaglandin E2 .
Topical cetirizine was used with good results and with no notable side effects for the treatment of androgenic alopecia. Because of this evidence and the absence of hormonal influence, cetirizine was considered suitable for this kind of hair loss .
Cetirizine is able to increase prostaglandins (PG) E and Fα synthesis, and thus, reduce inflammation. It also decreases prostaglandin D2 (PGD2) synthesis. Prostaglandins E and Fα influence positively hair follicle growth, and stimulate and maintain the anagen phase. So, by increasing the synthesis of prostaglandins E and Fα, cetirizine induces an increase in total and terminal hair density and hair diameter, and a reduction in vellus hair density.
A recent study has shown a significantly increased expression of prostaglandin D2 in the serum and lesional skin of alopecia areata patients than in controls. Also, a case report has demonstrated the improvement of diffuse alopecia caused by palbociclib for the treatment of breast cancer, using topical cetirizine 0.5% solution.
Dermoscopy is a non-invasive diagnostic utility, used to evaluate many skin and hair disorders. It may aid in the diagnosis of many uncertain hair disorders, one of which is alopecia areata. Different dermoscopic characteristics are seen in alopecia areata such as, black dots, yellow dots, tapering hairs (exclamation mark hairs). broken hairs and short vellus hairs.
- Conditions
- Alopecia Areata
- Being tested
- Topical Cetirizine 1 %, Topical betamethasone valerate 0.1%
- Keywords
- Cetirizine
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Cetirizine 1 %Drug
topical cetirizine belongs to anti histamines group
Topical betamethasone valerate 0.1%Drug
topical betamethasone valerate belongs to corticosteroids group
| Study group | Role | What they receive |
|---|---|---|
| A | patients with alopecia areata who will be treated with topical cetirizine 1% Receives: Drug: Topical Cetirizine 1 % | |
| B | patients with alopecia areata who will be treated with topical betamethasone valerate 0.1% Receives: Drug: Topical betamethasone valerate 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare topical cetirizine and betamethasone valerate in treatment of alopecia areata
compare the healing rate
Measured: baseline
Clinical evaluation by SALT score
an ideal objective method of follow-up and good evaluation of any therapeutic option
Measured: 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)
Measured: 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)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Esam Fathy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803070
- Sponsor's protocol ID
- Alopecia areata treatment
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28604133
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Cetirizine Versus Topical Betamethasone in Treatment of Localized Alopecia Areata
- ClinicalTrials.gov ID
- NCT05803070
- Acronym / sponsor ID
- Alopecia areata treatment
- Conditions
- Alopecia Areata
- Keywords
- Cetirizine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Apr 2023 (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.
Evaluate and compare the efficacy and safety of topical cetirizine 1%, versus topical betamethasone valerate 0.1% in the treatment of localized alopecia areata.
Detailed description
Alopecia areata (AA) is one of the commonest autoimmune non-cicatricial hair loss that affects different parts of hair-bearing areas of the body . Nearly 2% of the population at some stage of their life may be affected by alopecia areata while the prevalence of alopecia areata was reported to be between 0.1% to 0.2%. Alopecia areata can occur at any age, although it starts in the first three decades of life in most patients, and both sexes are equally affected. It can present clinically as a well-defined patch of hair loss, diffuse hair loss, reticulate hair loss, ophiasis, ophiasis inversus, alopecia totalis (complete loss of scalp hair), or alopecia universalis (hair loss of all over the body).
Many treatment options including topical, systemic, injectable and laser modalities have been used for the treatment of AA . Among the various treatment options for alopecia areata, topical corticosteroids as betamethasone valerate are considered as standard therapy.
There have been reports on the efficacy/adjunctive role of systemic antihistamines in alopecia areata. Moreover, fexofenadine was found to enhance hair regrowth in two cases of extensive resistant alopecia areata.
Cetirizine hydrochloride belongs to a family of medicines called antihistamines which has varied medical uses and is commonly used to relieve allergy symptoms such as watery eyes, runny nose, sneezing, hives, and itching. In addition, it has been demonstrated that cetirizine inhibits release of prostaglandin D2 and stimulates the release of prostaglandin E2 .
Topical cetirizine was used with good results and with no notable side effects for the treatment of androgenic alopecia. Because of this evidence and the absence of hormonal influence, cetirizine was considered suitable for this kind of hair loss .
Cetirizine is able to increase prostaglandins (PG) E and Fα synthesis, and thus, reduce inflammation. It also decreases prostaglandin D2 (PGD2) synthesis. Prostaglandins E and Fα influence positively hair follicle growth, and stimulate and maintain the anagen phase. So, by increasing the synthesis of prostaglandins E and Fα, cetirizine induces an increase in total and terminal hair density and hair diameter, and a reduction in vellus hair density.
A recent study has shown a significantly increased expression of prostaglandin D2 in the serum and lesional skin of alopecia areata patients than in controls. Also, a case report has demonstrated the improvement of diffuse alopecia caused by palbociclib for the treatment of breast cancer, using topical cetirizine 0.5% solution.
Dermoscopy is a non-invasive diagnostic utility, used to evaluate many skin and hair disorders. It may aid in the diagnosis of many uncertain hair disorders, one of which is alopecia areata. Different dermoscopic characteristics are seen in alopecia areata such as, black dots, yellow dots, tapering hairs (exclamation mark hairs). broken hairs and short vellus hairs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: Topical Cetirizine 1 %patients with alopecia areata who will be treated with topical cetirizine 1% |
| B | – | Drug: Topical betamethasone valerate 0.1%patients with alopecia areata who will be treated with topical betamethasone valerate 0.1% |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with alopecia areata who attend the outpatient clinic of Dematology department ,Assuit University hospital.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Topical Cetirizine 1 %topical cetirizine belongs to anti histamines group | Drug | A |
| Topical betamethasone valerate 0.1%topical betamethasone valerate belongs to corticosteroids group | Drug | B |
Primary outcome
Compare topical cetirizine and betamethasone valerate in treatment of alopecia areata
Time frame: baseline
compare the healing rate
Clinical evaluation by SALT score
Time frame: baseline
an ideal objective method of follow-up and good evaluation of any therapeutic option
Clinical evaluation by photographic evaluation
Time frame: baseline
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)
Clinical evaluation by patient's satisfaction level
Time frame: baseline
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 28604133Rossi 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia Areata, run by Assiut University.
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 11 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Esam Fathy, master (01226593916, mariamessam22112018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare topical cetirizine and betamethasone valerate in treatment of alopecia areata (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803070, which also lists 1 linked publication.
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 7 Apr 2023.