ALOPECIA AREATAPhase 3MP3NCT02037191
The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade
A Phase 3 study testing Methotrexate in people with ALOPECIA AREATA, run by University Hospital, Rouen at 2 sites in France.
Trial summary
Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in the treatment of severe types of AA. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ALOPECIA AREATA
- What is being tested?
- Methotrexate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2014to Dec 2017
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - age 18 to 70 years old
- - informed consent,
- - severe type of AA defined as : 3.1 - AA totalis universalis 3.2 - evolving for more than 6 months despite previous treatments including photothérapy (PUVA oru UVB), applications of super potent topical corticosteroid ( clobetasol propionate), applications of minoxidil 5%, or IV pulse corticosteroids 3.3 - DLQI score superior or equal to 10
Who cannot join
- Pregnant or breast feeding women
- VIH + patients
- active hepatitis B or C
- treatment with immunosuppressant (ciclosporine, mycophénolate mofetil
- , cyclophosphamide, azathioprine, méthotrexate) within 2 months before inclusion
- severe cardiac arythma or severe cardiac insufficiency or severe coronary disease
Show all 18Show fewer
- liver disorder
- alcool consumption
- renal failure
- Severe diabetes mellitus
- past history of severe infection
- past history of néoplasiae ( excluding BCC),
- Karnofsky index <à 50 %
- severe lung disorder
- mental impairment
- symptomatic osteoporosis
- blood cytopénia (hémoglobine < 10 g/l ; leucocytes< 3000/mm3, platelets< 100 000/mm3)
- albuminémia < 25 g/l
Trial locations and contacts
2 sites in 1 country.
France2 sites
Head Dermatology Department
Rouen, Haute Normandie, 76031
CHU de Rouen - Hôpitaux de Rouen
Rouen, Seine Maritime, 76031
About this study
Official title: RANDOMIZED DOUBLE-BLIND STUDY MULTICENTRIQUE TESTING THE EFFICIENCY OF the METHOTREXATE AT PATIENTS AFFECTED BY GRAVE PELADE (METHOTREXATE VERSUS PLACEBO WITH SECONDARY TREATMENT BY METHOTREXATE and PREDNISONE)
Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in the treatment of severe types of AA.
Read the detailed description
Background: Alopecia areata (AA) is an auto immune disorder. Chronic and severe types of AA have a major impact on patients' quality of life. Treatment of severe types of AA include phototherapy, pulse IV corticosteroids, topical immunotherapy. These treatments are poorly effective in severe types of AA, since the rate of hair regrowth remains lower than 10%. Methotrexate is an immunosuppressant which is used in many autoimmune skin disorders.
Aim: To assess the safety and efficacy of methotrexate versus placebo in the treatment of severe types of AA.
Design: Patients will be randomly assigned to receive methotrexate 20 to 25 mg / week for 6 months. Patients who will experience at least a 25% hair regrowth after 5 months will continue methotrexate or placebo from month 6 to the end of the study (month 12). Non responder patients will be re randomized to receive either methotrexate alone or associated with prednisone 0.3 mg/Kg/day from month 6 to the end of the study (month 12).
Study Design Primary outcome Rate of complete or almost complete hair regrowth at the month 12 evaluation in patients treated with methotrexate or placebo who have not been re randomized after the month 5 evaluation and have staid in their initial group of randomization Secondary outcomes
- Rate of Global Regrowth Assesment (GRA) at month 6 and 12 .
- Delay of hair regrowth
- Rate of relapse
- Quality of life
- Safety
Arm description Arm A: methotrexate 20 to 25 mg / week for 6 months. Arm B placebo Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12).
Non responder patients in both arms A and B will be re-randomized to receive from month 6 to the end of the study (month 12):
- methotrexate alone or
- methotrexate associated with prednisone 0.3 mg/Kg/day 10 A study population Adult patients with severe types of AA evolving without hair regrowth for at least 6 months despite previous treatments with impaired quality of life
Eligibility criteria Inclusion criteria
- age 18 TO 70 years old
- informed consent,
- severe type of AA defined as : 3.1 - AA totalis universalis 3.2 - evolving for more than 6 months despite previous treatments including photothérapy (PUVA oru UVB), applications of super potent topical corticosteroid ( clobetasol propionate), applications of minoxidil 5%, or IV pulse corticosteroids 3.3 - DLQI score inferior or equal to 10
Non inclusion criteria
- Pregnant or breast feeding women
- VIH + patients
- active hepatitis B or C
- treatment with immunosuppressant (ciclosporine, mycophénolate mofetil, cyclophosphamide, azathioprine, méthotrexate) within 2 months before inclusion
- severe cardiac arythma or severe cardiac insufficiency or severe coronary disease
- liver disorder
- alcool consumption
- renal failure
- Severe diabetes mellitus
- past history of severe infection
- past history of néoplasiae ( excluding BCC),
- Karnofsky index <à 50 %
- severe lung disorder
- mental impairment
- symptomatic osteoporosis
- blood cytopénia (hémoglobine < 10 g/l ; leucocytes< 3000/mm3, platelets< 100 000/mm3)
- albuminémia < 25 g/l
- Conditions
- ALOPECIA AREATA
- Being tested
- Methotrexate, Placebo
- Keywords
- ALOPECIA AREATA, TREATMENT METHOTREXATE
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Arm A: methotrexate 20 to 25 mg / week for 6 months.
Non responder patients in arm A will be re-randomized to receive from month 6 to the end of the study (month 12):
methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day
PlaceboDrug
Non responder patients in arm B will be re-randomized to receive from month 6 to the end of the study (month 12):
methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day
| Study group | Role | What they receive |
|---|---|---|
| ARM A : METHOTREXATE | Placebo comparator | Arm A: methotrexate 20 to 25 mg / week for 6 months. Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12).
Non responder patients in both arms A and B will be re-randomized to receive from month 6 to the end of the study (month 12):
* methotrexate alone or
* methotrexate associated with prednisone 0.3 mg/Kg/day Receives: Drug: Methotrexate |
| ARM B : PLACEBO | Placebo comparator | Arm B placebo Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12).
Non responder patients in both arms A and B will be re-randomized to receive from month 6 to the end of the study (month 12):
* methotrexate alone or
* methotrexate associated with prednisone 0.3 mg/Kg/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
OUTCOME MESURE
primary outcome Rate of complete or almost complete hair regrowth at the month 12 evaluation in patients treated with methotrexate or placebo who have not been re randomized after the month 5 evaluation and have staid in their initial group of randomization
Measured: MONTH12
Secondary outcomes (1)
SECONDARY OUTCOME MEASURE
1 Rate of Global Regrowth Assesment (GRA) at month 6 and 12 .
- 2 Delay of hair regrowth
- 3 Rate of relapse
- 4 Quality of life
- 5 Safety
Measured: MONTH 6 TO 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2017
- Study completionDec 2017
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 University Hospital, RouenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PASCAL JOLY, PROFESSOR, Principal investigator, CHU - Hôpitaux de Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037191
- Sponsor's protocol ID
- 2011/121/HP
- Acronym
- MP3
- Status last verified
- May 2018
- First submitted
- 13 Jan 2014
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Joly P, Lafon A, Houivet E, Donnadieu N, Richard MA, Dupuy A, Delaporte E, Bernard P, Machet L, Tosti A, Del Marmol V, Grimalt R, de Viragh PA, Benichou J, Chosidow O, Assouly P, Reygagne P. Efficacy of Methotrexate Alone vs Methotrexate Plus Low-Dose Prednisone in Patients With Alopecia Areata Totalis or Universalis: A 2-Step Double-Blind Randomized Clinical Trial. JAMA Dermatol. 2023 Apr 1;159(4):403-410. doi: 10.1001/jamadermatol.2022.6687.
PubMed 36884234
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED DOUBLE-BLIND STUDY MULTICENTRIQUE TESTING THE EFFICIENCY OF the METHOTREXATE AT PATIENTS AFFECTED BY GRAVE PELADE (METHOTREXATE VERSUS PLACEBO WITH SECONDARY TREATMENT BY METHOTREXATE and PREDNISONE)
- ClinicalTrials.gov ID
- NCT02037191
- Acronym / sponsor ID
- MP3 / 2011/121/HP
- Conditions
- ALOPECIA AREATA
- Keywords
- ALOPECIA AREATA, TREATMENT METHOTREXATE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jan 2014 (estimated)
- 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.
Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in the treatment of severe types of AA.
Detailed description
Background: Alopecia areata (AA) is an auto immune disorder. Chronic and severe types of AA have a major impact on patients' quality of life. Treatment of severe types of AA include phototherapy, pulse IV corticosteroids, topical immunotherapy. These treatments are poorly effective in severe types of AA, since the rate of hair regrowth remains lower than 10%. Methotrexate is an immunosuppressant which is used in many autoimmune skin disorders.
Aim: To assess the safety and efficacy of methotrexate versus placebo in the treatment of severe types of AA.
Design: Patients will be randomly assigned to receive methotrexate 20 to 25 mg / week for 6 months. Patients who will experience at least a 25% hair regrowth after 5 months will continue methotrexate or placebo from month 6 to the end of the study (month 12). Non responder patients will be re randomized to receive either methotrexate alone or associated with prednisone 0.3 mg/Kg/day from month 6 to the end of the study (month 12).
Study Design Primary outcome Rate of complete or almost complete hair regrowth at the month 12 evaluation in patients treated with methotrexate or placebo who have not been re randomized after the month 5 evaluation and have staid in their initial group of randomization Secondary outcomes
- Rate of Global Regrowth Assesment (GRA) at month 6 and 12 .
- Delay of hair regrowth
- Rate of relapse
- Quality of life
- Safety
Arm description Arm A: methotrexate 20 to 25 mg / week for 6 months. Arm B placebo Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12).
Non responder patients in both arms A and B will be re-randomized to receive from month 6 to the end of the study (month 12):
- methotrexate alone or
- methotrexate associated with prednisone 0.3 mg/Kg/day 10 A study population Adult patients with severe types of AA evolving without hair regrowth for at least 6 months despite previous treatments with impaired quality of life
Eligibility criteria Inclusion criteria
- age 18 TO 70 years old
- informed consent,
- severe type of AA defined as : 3.1 - AA totalis universalis 3.2 - evolving for more than 6 months despite previous treatments including photothérapy (PUVA oru UVB), applications of super potent topical corticosteroid ( clobetasol propionate), applications of minoxidil 5%, or IV pulse corticosteroids 3.3 - DLQI score inferior or equal to 10
Non inclusion criteria
- Pregnant or breast feeding women
- VIH + patients
- active hepatitis B or C
- treatment with immunosuppressant (ciclosporine, mycophénolate mofetil, cyclophosphamide, azathioprine, méthotrexate) within 2 months before inclusion
- severe cardiac arythma or severe cardiac insufficiency or severe coronary disease
- liver disorder
- alcool consumption
- renal failure
- Severe diabetes mellitus
- past history of severe infection
- past history of néoplasiae ( excluding BCC),
- Karnofsky index <à 50 %
- severe lung disorder
- mental impairment
- symptomatic osteoporosis
- blood cytopénia (hémoglobine < 10 g/l ; leucocytes< 3000/mm3, platelets< 100 000/mm3)
- albuminémia < 25 g/l
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A : METHOTREXATE | Placebo comparator | Drug: MethotrexateArm A: methotrexate 20 to 25 mg / week for 6 months. Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12). Non responder patients in both arms A and B will be re-randomized to receive from month 6 to the end of the study (month 12): * methotrexate alone or * methotrexate associated with prednisone 0.3 mg/Kg/day |
| ARM B : PLACEBO | Placebo comparator | Drug: PlaceboArm B placebo Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12). Non responder patients in both arms A and B will be re-randomized to receive from month 6 to the end of the study (month 12): * methotrexate alone or * methotrexate associated with prednisone 0.3 mg/Kg/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - age 18 to 70 years old
- - informed consent,
- - severe type of AA defined as : 3.1 - AA totalis universalis 3.2 - evolving for more than 6 months despite previous treatments including photothérapy (PUVA oru UVB), applications of super potent topical corticosteroid ( clobetasol propionate), applications of minoxidil 5%, or IV pulse corticosteroids 3.3 - DLQI score superior or equal to 10
Key exclusion criteria (18 listed)
- Pregnant or breast feeding women
- VIH + patients
- active hepatitis B or C
- treatment with immunosuppressant (ciclosporine, mycophénolate mofetil
- , cyclophosphamide, azathioprine, méthotrexate) within 2 months before inclusion
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 |
|---|---|---|
| MethotrexateAlso: Arm A: methotrexate 20 to 25 mg / week for 6 months.Non responder patients in arm A will be re-randomized to receive from month 6 to the end of the study (month 12): methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day | Drug | ARM A : METHOTREXATE |
| PlaceboNon responder patients in arm B will be re-randomized to receive from month 6 to the end of the study (month 12): methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day | Drug | ARM B : PLACEBO |
Primary outcome
OUTCOME MESURE
Time frame: MONTH12
primary outcome Rate of complete or almost complete hair regrowth at the month 12 evaluation in patients treated with methotrexate or placebo who have not been re randomized after the month 5 evaluation and have staid in their initial group of randomization
1 secondary outcome
SECONDARY OUTCOME MEASURE
Time frame: MONTH 6 TO 12
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 29 May 2018.
- Derived from this study: PubMed 36884234Joly P, Lafon A, Houivet E, Donnadieu N, Richard MA, Dupuy A, Delaporte E, Bernard P, Machet L, Tosti A, Del Marmol V, Grimalt R, de Viragh PA, Benichou J, Chosidow O, Assouly P, Reygagne P. Efficacy of Methotrexate Alone vs Methotrexate Plus Low-Dose Prednisone in Patients With Alopecia Areata Totalis or Universalis: A 2-Step Double-Blind Randomized Clinical Trial. JAMA Dermatol. 2023 Apr 1;159(4):403-410. doi: 10.1001/jamadermatol.2022.6687.
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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.
PASCAL JOLY, PROFESSOR principal investigator
CHU - Hôpitaux de Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate in people with ALOPECIA AREATA, run by University Hospital, Rouen at 2 sites in France.
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 18 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 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
OUTCOME MESURE (time frame: MONTH12). 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 NCT02037191, 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 29 May 2018.