Frontal Fibrosing AlopeciaFFANCT02467101
Study to Assess the Efficacy of Intralesional Corticosteroid on the Treatment of Frontal Fibrosing Alopecia
A study testing Corticosteroid/Saline in people with Frontal Fibrosing Alopecia, run by Rubina Alves at 1 site in Spain.
Trial summary
The purpose of this study is to determine the efficacy of treatment with intralesional injection of corticosteroids on the treatment of Frontal Fibrosing Alopecia (compared with placebo), between three months, six months and baseline. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Frontal Fibrosing Alopecia
- What is being tested?
- Corticosteroid/Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Dec 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the diagnosis of Frontal Fibrosing Alopecia
Who cannot join
- Pregnancy
- Patient unable to accomplishing all fases of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Double-blind, Placebo Controlled Study to Assess the Efficacy of Intralesional Corticoid on the Treatment of Frontal Fibrosing Alopecia
The purpose of this study is to determine the efficacy of treatment with intralesional injection of corticosteroids on the treatment of Frontal Fibrosing Alopecia (compared with placebo), between three months, six months and baseline.
Read the detailed description
Frontal fibrosing alopecia (FFA) is a primary lymphocytic cicatricial alopecia, that was first described in postmenopausal women, by Kossard in 1994. Since then, FFA has also been reported in premenopausal women and rarely in men.
The exact cause of FFA is unknown. One possible reason can be the disturbed immune response to some component of the scalp hair follicles, however, whether or not the hair loss is caused by hormonal fluctuations is under question. Some authors, consider that FFA is a variant of liquen planopilaris (LPP). Whether FFA is truly an LPP variant or is a distinct entity with shared clinical features remains to be determined. FFA was also diagnosed in family members (mother and daughter) suggesting a possible genetic contribution.
Clinically, it is characterized by progressive frontal and temporoparietal recession of the hairline due to inflammatory destruction of hair follicles. Hair loss occurs in a band-like distribution and the depth of recession can be from 0,5-8 cm. Often, a small number of isolated hairs are spared within the band of alopecia.
Loss of eyebrows (partial or complete) is a finding in FFA and in some cases, can precede the hairline recession. The affected skin is atrophic, shiny, and often lighter than the chronically sun-exposed forehead skin.
The diagnosis of FFA is usually made on the basis of clinical findings, and laboratory tests are rarely required. Dermoscopy, a noninvasive tool can help for the diagnosis of FFA; The dermoscopic features of FFA are: Absence of follicular openings, perifollicular scale, and a feeble perifollicular erythema. Perifollicular erythema at the receding hairline may be a sign of active disease.
Since the first description of FFA, many reports have been published, and the number of new cases of FFA appears to be increasing.
Currently, there are no evidence-based studies to guide treatment and there is no clearly defined line of treatment for the condition. Therefore treatment options vary among clinicians.
The aim of this study is to find if intralesional triamcinolone acetonide (compared to area treated with placebo) may help to halt or slow down the progression of this disease.
The patients are divided into two groups (A and B):
- Group A: right half-head (active border of the disease): treatment with intralesional triamcinolone acetonide left half-head (active border of the disease): placebo (saline solution)
- Group B: right half-head (active border of the disease):placebo (saline solution) left half-head (active border of the disease): intralesional triamcinolone acetonide
The aim of this study is to find if intralesional triamcinolone may help to halt or slow down the progres- sion of this disease.
All patients provide written informed consent before participating in the study, which is performed according to the Declaration of Helsinki.
- Conditions
- Frontal Fibrosing Alopecia
- Being tested
- Corticosteroid/Saline
- Keywords
- cicatricial alopecia, treatment, placebo, double-blind
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid/SalineOther
Also called Frontal fibrosing alopecia, Cicatricial alopecia, Alopecia, Hair loss
Corticosteroid/Saline
Two groups were defined: group A and group B.
- Group A receives treatment with intralesional triamcinolone acetonide on the right half-head and placebo on the left half-head
- Group B receives administration of intralesional triamcinolone acetonide on left half-head and placebo on the right half-head.
Same patient will be injected with intralesional triamcinolone acetonide and a saline solution.
Each patient will be injected on half-head.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid/Saline | Experimental | Corticosteroid/Saline
Patients with diagnosis of frontal fibrosing alopecia are included in the study. The diagnosis is based on the clinical findings of frontal and temporoparietal hairline recession with loss of follicular ostia.
In the same patient, intralesional triamcinolone acetone will be injected to half-head (in the active border of hairline) and in the other half-head the patient will be injected with saline solution (placebo).
The intralesional triamcinolone acetone (40 mg/ml)l) of 0,1 mL/1cm, is given along the frontal and frontoparietal hairline every 4 weeks (3 sessions).
This study includes 4 visits: 3 visits of treatment (with 1-month interval) and 1 visit of follow-up (month 6). Receives: Other: Corticosteroid/Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phototricogram of two areas of the scalp
Measuring hair count (number of hairs/0.65 cm2) by comparison with 6 months and baseline
Measured: 6 months
Secondary outcomes (1)
Global photographs of the scalp
The evaluation of hair growth will be assessed by comparison of standardized images between baseline and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontal Fibrosing AlopeciaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rubina Alves
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Responsible party
- Sponsor-investigator, Rubina Alves, Universitat Internacional de Catalunya
- Investigators
- Rubina Alves, M.D., Principal investigator, Universitat Internacional CatalunyaJuan Antonio Moreno, M.D., Principal investigator, Universitat Internacional CatalunyaRamon Grimalt, M.D.; PhD, Study director, Universitat Internacional Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467101
- Sponsor's protocol ID
- UIC-FFA
- Other IDs
- UICatalunya
- Acronym
- FFA
- Status last verified
- May 2015
- First submitted
- 27 May 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double-blind, Placebo Controlled Study to Assess the Efficacy of Intralesional Corticoid on the Treatment of Frontal Fibrosing Alopecia
- ClinicalTrials.gov ID
- NCT02467101
- Acronym / sponsor ID
- FFA / UIC-FFA
- Conditions
- Frontal Fibrosing Alopecia
- Keywords
- cicatricial alopecia, treatment, placebo, double-blind
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rubina AlvesUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Jun 2015 (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.
The purpose of this study is to determine the efficacy of treatment with intralesional injection of corticosteroids on the treatment of Frontal Fibrosing Alopecia (compared with placebo), between three months, six months and baseline.
Detailed description
Frontal fibrosing alopecia (FFA) is a primary lymphocytic cicatricial alopecia, that was first described in postmenopausal women, by Kossard in 1994. Since then, FFA has also been reported in premenopausal women and rarely in men.
The exact cause of FFA is unknown. One possible reason can be the disturbed immune response to some component of the scalp hair follicles, however, whether or not the hair loss is caused by hormonal fluctuations is under question. Some authors, consider that FFA is a variant of liquen planopilaris (LPP). Whether FFA is truly an LPP variant or is a distinct entity with shared clinical features remains to be determined. FFA was also diagnosed in family members (mother and daughter) suggesting a possible genetic contribution.
Clinically, it is characterized by progressive frontal and temporoparietal recession of the hairline due to inflammatory destruction of hair follicles. Hair loss occurs in a band-like distribution and the depth of recession can be from 0,5-8 cm. Often, a small number of isolated hairs are spared within the band of alopecia.
Loss of eyebrows (partial or complete) is a finding in FFA and in some cases, can precede the hairline recession. The affected skin is atrophic, shiny, and often lighter than the chronically sun-exposed forehead skin.
The diagnosis of FFA is usually made on the basis of clinical findings, and laboratory tests are rarely required. Dermoscopy, a noninvasive tool can help for the diagnosis of FFA; The dermoscopic features of FFA are: Absence of follicular openings, perifollicular scale, and a feeble perifollicular erythema. Perifollicular erythema at the receding hairline may be a sign of active disease.
Since the first description of FFA, many reports have been published, and the number of new cases of FFA appears to be increasing.
Currently, there are no evidence-based studies to guide treatment and there is no clearly defined line of treatment for the condition. Therefore treatment options vary among clinicians.
The aim of this study is to find if intralesional triamcinolone acetonide (compared to area treated with placebo) may help to halt or slow down the progression of this disease.
The patients are divided into two groups (A and B):
- Group A: right half-head (active border of the disease): treatment with intralesional triamcinolone acetonide left half-head (active border of the disease): placebo (saline solution)
- Group B: right half-head (active border of the disease):placebo (saline solution) left half-head (active border of the disease): intralesional triamcinolone acetonide
The aim of this study is to find if intralesional triamcinolone may help to halt or slow down the progres- sion of this disease.
All patients provide written informed consent before participating in the study, which is performed according to the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid/Saline | Experimental | Other: Corticosteroid/SalineCorticosteroid/Saline Patients with diagnosis of frontal fibrosing alopecia are included in the study. The diagnosis is based on the clinical findings of frontal and temporoparietal hairline recession with loss of follicular ostia. In the same patient, intralesional triamcinolone acetone will be injected to half-head (in the active border of hairline) and in the other half-head the patient will be injected with saline solution (placebo). The intralesional triamcinolone acetone (40 mg/ml)l) of 0,1 mL/1cm, is given along the frontal and frontoparietal hairline every 4 weeks (3 sessions). This study includes 4 visits: 3 visits of treatment (with 1-month interval) and 1 visit of follow-up (month 6). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with the diagnosis of Frontal Fibrosing Alopecia
Key exclusion criteria (2 listed)
- Pregnancy
- Patient unable to accomplishing all fases of treatment
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 |
|---|---|---|
| Corticosteroid/SalineAlso: Frontal fibrosing alopecia, Cicatricial alopecia, Alopecia, Hair lossCorticosteroid/Saline Two groups were defined: group A and group B. * Group A receives treatment with intralesional triamcinolone acetonide on the right half-head and placebo on the left half-head * Group B receives administration of intralesional triamcinolone acetonide on left half-head and placebo on the right half-head. Same patient will be injected with intralesional triamcinolone acetonide and a saline solution. Each patient will be injected on half-head. | Other | Corticosteroid/Saline |
Primary outcome
Phototricogram of two areas of the scalp
Time frame: 6 months
Measuring hair count (number of hairs/0.65 cm2) by comparison with 6 months and baseline
1 secondary outcome
Global photographs of the scalp
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
Related trials for Frontal Fibrosing Alopecia
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Deucravacitinib in the Treatment of Cicatricial Alopecias
Central Centrifugal Cicatricial Alopecia, Frontal Fibrosing Alopecia
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The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)
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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.
Rubina Alves, M.D. principal investigator
Universitat Internacional Catalunya
Juan Antonio Moreno, M.D. principal investigator
Universitat Internacional Catalunya
Ramon Grimalt, M.D.; PhD study director
Universitat Internacional Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid/Saline in people with Frontal Fibrosing Alopecia, run by Rubina Alves at 1 site in Spain.
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 2 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 9 Jun 2015. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubina Alves, M.D.. (00351913814831, rubinaalves@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phototricogram of two areas of the scalp (time frame: 6 months). 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 9 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.