Alopecia AreataNCT04680234
Superficial Cryotherapy Versus Microneedling in Alopecia Areata
A study testing DMEP kit and Dermapen in people with Alopecia Areata, run by Sohag University at 1 site in Egypt.
Trial summary
This study is randomized comparative analytical prospective study that included patients with mild and moderate alopecia areata. Patients was divided into two groups Patients in the first group underwent Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C (Cryotherapy group). Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- DMEP kit and Dermapen
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jun 2020
- Phase
- Interventional
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ِAlopecia areata patients
Who cannot join
- Alopecia totalis and universalis
- ِAge less than four years.
- ِPregnancy or breast-feeding.
- ِActive infection at the site alopecia patch(s).
- ِInflammation ate site of the alopecia patches
- ِIntolerance to cold.
- ِAssociated systemic illness such as thyroid, pernicious anaemia, diabetes mellitus, autoimmune connective tissue diseases.
- ِPrevious treatment for alopecia areata over the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between the Effect of Superficial Cryotherapy Using Dimethyl Ether and Propane Mixture and Microneedling in Treatment of Alopecia Areata
This study is randomized comparative analytical prospective study that included patients with mild and moderate alopecia areata. Patients was divided into two groups Patients in the first group underwent Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C (Cryotherapy group). Patients in the second group underwent Microneedling (Microneedling group). A total of six sessions were done at 2 weeks interval. Patients were followed-up for next 3 months to evaluate the persistence of hair regrowth after therapy. Patients were assessed at baseline and during follow up using photography, Dermoscopy, SALT score and regrowth scale.
- Conditions
- Alopecia Areata
- Being tested
- DMEP kit, Dermapen
- Keywords
- alopecia areata, Microneedling, Cryotherapy
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMEP kitProcedure or surgery
Superficial Cryotherapy using dimethyl ether and propane (DMEP) at -57C
DermapenDevice
Under aseptic precautions, the dermapen was moved on the alopecic patches diagonally, vertically and horizontally 4 to 5 times in each direction Pin point bleeding was taken as an end point
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy group | Active comparator | Patients underwent superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C very 2 weeks for maximum six sessions Receives: Procedure: DMEP kit |
| Microneedling group | Active comparator | Patients underwent microneedling 2 weeks for maximum six sessions Receives: Device: Dermapen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regrowth Scale
0 score (regrowth < 10%) no response
- score (regrowth 11-25%) poor response
- score (regrowth 26-50%) fair response
- score (regrowth 51-75%) satisfactory response
- score (regrowth ≥ 75%) excellent response.
Measured: Change in regrowth scale from baseline to 3 months follow after end of sessions
Secondary outcomes (1)
SALT score
SALT score is the sum of the percentage of hair loss in all the abovementioned areas. For example, if the percentage hair loss in vertex, right profile, left profile, and posterior aspect is 20, 30, 40, and 50% respectively; then, SALT score = (20 × 0.4) = (30 × 0.18) + (40 × 0.18) + (50 × 0.24) = 8 + 5.4 + 7.2 + 12 = 32.6.
Measured: Change in salt score from baseline to 3 months follow after end of sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided into two groups (randomly assigned and comparably cross matched for age and sex) Cryotherapy group (No.= 50): Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C Microneedling group (No. = 50): Microneedling
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Abu elbaha Gouda, Sohag University
- Investigators
- Zeinab A Gouda, MSc, Study director, Sohag Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680234
- Sponsor's protocol ID
- Alopecia2020
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Superficial Cryotherapy Using Dimethyl Ether and Propane Mixture and Microneedling in Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT04680234
- Acronym / sponsor ID
- Alopecia2020
- Conditions
- Alopecia Areata
- Keywords
- alopecia areata, Microneedling, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 22 Dec 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.
This study is randomized comparative analytical prospective study that included patients with mild and moderate alopecia areata. Patients was divided into two groups Patients in the first group underwent Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C (Cryotherapy group). Patients in the second group underwent Microneedling (Microneedling group). A total of six sessions were done at 2 weeks interval. Patients were followed-up for next 3 months to evaluate the persistence of hair regrowth after therapy. Patients were assessed at baseline and during follow up using photography, Dermoscopy, SALT score and regrowth scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be divided into two groups (randomly assigned and comparably cross matched for age and sex) Cryotherapy group (No.= 50): Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C Microneedling group (No. = 50): Microneedling
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy group | Active comparator | Procedure: DMEP kitPatients underwent superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C very 2 weeks for maximum six sessions |
| Microneedling group | Active comparator | Device: DermapenPatients underwent microneedling 2 weeks for maximum six sessions |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ِAlopecia areata patients
Key exclusion criteria (8 listed)
- Alopecia totalis and universalis
- ِAge less than four years.
- ِPregnancy or breast-feeding.
- ِActive infection at the site alopecia patch(s).
- ِInflammation ate site of the alopecia patches
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 |
|---|---|---|
| DMEP kitSuperficial Cryotherapy using dimethyl ether and propane (DMEP) at -57C | Procedure or surgery | Cryotherapy group |
| DermapenUnder aseptic precautions, the dermapen was moved on the alopecic patches diagonally, vertically and horizontally 4 to 5 times in each direction Pin point bleeding was taken as an end point | Device | Microneedling group |
Primary outcome
Regrowth Scale
Time frame: Change in regrowth scale from baseline to 3 months follow after end of sessions
0 score (regrowth < 10%) no response 1. score (regrowth 11-25%) poor response 2. score (regrowth 26-50%) fair response 3. score (regrowth 51-75%) satisfactory response 4. score (regrowth ≥ 75%) excellent response.
1 secondary outcome
SALT score
Time frame: Change in salt score from baseline to 3 months follow after end of sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: Yes. data will be provided upon request
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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.
Zeinab A Gouda, MSc study director
Sohag Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMEP kit and Dermapen in people with Alopecia Areata, run by Sohag University 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 22 Dec 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Regrowth Scale (time frame: Change in regrowth scale from baseline to 3 months follow after end of sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2020.