Alopecia AreataPhase 4NCT04228029
Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
A Phase 4 study testing Carboxytherapy and Intralesional Steroid Injection in people with Alopecia Areata, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Patients with three lesions of alopecia areata are randomly recruited in this study. Each lesion is randomized in to receiving either carboxytherapy in one lesion, intralesional steroids in another lesion and combination of both in the third lesion. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Carboxytherapy and Intralesional Steroid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2019to 20 Apr 2020
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- early localized scalp alopecia areata
- patients who did not receive any medication for at least 2 months before starting the study Patients who agreed to join the study and signed written consent.
Who cannot join
- pregnant, and lactating females and those with unrealistic expectation.
- Alopecia totalis or universalis or ophiasis or cicatrising alopecia
- Usage of systemic treatment of alopecia areata 2 months prior to the study.
- Any scalp lesion within the treated area
- Bleeding diathesis, severe anemia or platelet disorders
- Medical conditions such as autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Carboxytherapy Play a Role in Alopecia Areata Either Solely or in Combination? Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
Patients with three lesions of alopecia areata are randomly recruited in this study. Each lesion is randomized in to receiving either carboxytherapy in one lesion, intralesional steroids in another lesion and combination of both in the third lesion.
Treatment period is 3 months followed by a follow-up period of 2 months.
- Conditions
- Alopecia Areata
- Being tested
- Carboxytherapy, Intralesional Steroid Injection
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboxytherapyDevice
Carbon dioxide (CO2) gas in injection form
Intralesional Steroid InjectionDrug
triamcinolone acetonide 8 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Carboxytherapy | Active comparator | Not described Receives: Device: Carboxytherapy |
| Intralesional steroids | Active comparator | Not described Receives: Drug: Intralesional Steroid Injection |
| Combination of carboxytherapy and intralesional steroids | Active comparator | Not described Receives: Device: Carboxytherapy; Drug: Intralesional Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Alopecia Tool (SALT) score
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both Minimum value is 0% and maximum value is100% the higher the score the more the hair loss
Measured: 6months-1 year
Dermoscopy
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both through counting number dystrophic hair, tapered hair, regrowing hair, black dots, and yellow dots
Measured: 6months-1 year
blinded observer evaluation by use of photography
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
Measured: 6months-1 year
patient satisfaction rate
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
Measured: 6months-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start20 Aug 2019
- Primary completion20 Feb 2020 (estimated)
- Study completion20 Apr 2020 (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.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana F Hilal, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228029
- Sponsor's protocol ID
- KasrEliniH
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Metwally D, Abdel-Fattah R, Hilal RF. Comparative study for treatment of alopecia areata using carboxy therapy, intralesional corticosteroids, and a combination of both. Arch Dermatol Res. 2022 Mar;314(2):167-182. doi: 10.1007/s00403-021-02201-6. Epub 2021 Mar 19.
PubMed 33742252
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Carboxytherapy Play a Role in Alopecia Areata Either Solely or in Combination? Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
- ClinicalTrials.gov ID
- NCT04228029
- Acronym / sponsor ID
- KasrEliniH
- Conditions
- Alopecia Areata
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 20 Feb 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 14 Jan 2020 (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.
Patients with three lesions of alopecia areata are randomly recruited in this study. Each lesion is randomized in to receiving either carboxytherapy in one lesion, intralesional steroids in another lesion and combination of both in the third lesion.
Treatment period is 3 months followed by a follow-up period of 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carboxytherapy | Active comparator | Device: Carboxytherapy |
| Intralesional steroids | Active comparator | Drug: Intralesional Steroid Injection |
| Combination of carboxytherapy and intralesional steroids | Active comparator | Device: Carboxytherapy, Drug: Intralesional Steroid Injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- early localized scalp alopecia areata
- patients who did not receive any medication for at least 2 months before starting the study Patients who agreed to join the study and signed written consent.
Key exclusion criteria (6 listed)
- pregnant, and lactating females and those with unrealistic expectation.
- Alopecia totalis or universalis or ophiasis or cicatrising alopecia
- Usage of systemic treatment of alopecia areata 2 months prior to the study.
- Any scalp lesion within the treated area
- Bleeding diathesis, severe anemia or platelet disorders
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 |
|---|---|---|
| CarboxytherapyCarbon dioxide (CO2) gas in injection form | Device | Carboxytherapy, Combination of carboxytherapy and intralesional steroids |
| Intralesional Steroid Injectiontriamcinolone acetonide 8 mg/mL | Drug | Combination of carboxytherapy and intralesional steroids, Intralesional steroids |
Primary outcome
Severity of Alopecia Tool (SALT) score
Time frame: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both Minimum value is 0% and maximum value is100% the higher the score the more the hair loss
Dermoscopy
Time frame: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both through counting number dystrophic hair, tapered hair, regrowing hair, black dots, and yellow dots
blinded observer evaluation by use of photography
Time frame: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
patient satisfaction rate
Time frame: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 33742252Metwally D, Abdel-Fattah R, Hilal RF. Comparative study for treatment of alopecia areata using carboxy therapy, intralesional corticosteroids, and a combination of both. Arch Dermatol Res. 2022 Mar;314(2):167-182. doi: 10.1007/s00403-021-02201-6. Epub 2021 Mar 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carboxytherapy and Intralesional Steroid Injection in people with Alopecia Areata, run by Kasr El Aini Hospital 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 2 inclusion and 6 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 14 Jan 2020. 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?
Results are not available in the source record.
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?
Severity of Alopecia Tool (SALT) score (time frame: 6months-1 year). 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 NCT04228029, 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 14 Jan 2020.