Alopecia AreataPhase 4NCT04793945
Excimer Light and Topical Steroid in Treatment of Alopecia Areata
A Phase 4 study testing topical steroid and 308nm-Excimer light therapy in people with Alopecia Areata, run by Assiut University.
Trial summary
Alopecia areata is a polygenic autoimmune disease causing hair loss, particularly during the anagen phase of hair growth This condition has a lifetime risk of about 2.1% of the world population and the cumulative incidence seems to rise linearly with age . Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- topical steroid and 308nm-Excimer light therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Sep 2022
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 16-40 years,
- Good general health,
- A clinical diagnosis of multiple Alopecia Areata of the scalp.
- Hair loss <25 percent of the total scalp.
- No use of drugs or hair care products influencing hair growth in the last 2 months.
Who cannot join
- Other causes of hair loss (like endocrine or immunological diseases).
- Skin disease in the treatment area.
- Pregnant or lactating patients.
- Hair transplantation history.
- Photosensitivity history.
- Malignant tumor history.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy of Combining 308 Nm-Excimer Light and Topical Steroid in the Treatment of Alopecia Areata
Alopecia areata is a polygenic autoimmune disease causing hair loss, particularly during the anagen phase of hair growth This condition has a lifetime risk of about 2.1% of the world population and the cumulative incidence seems to rise linearly with age .
Patchy non scarring hair loss on the scalp is the most common clinical presentation, although it can also occur elsewhere . In addition to patchy Alopecia Areata , a more severe form, alopecia totalis , presents with diffuse hair loss across the scalp. In the most severe form, alopecia universalis , hair loss occurs on all areas of the body, including the beard, eyelashes, and extremities .
Read the detailed description
Alopecia Areata can have a large impact on patients' quality of life, causing both cosmetic and psychosocial distress. Studies on the impact of hair loss have shown high levels of self-consciousness, jealousy, embarrassment, depression, introversion, and decreased self-esteem .
Alopecia Areata can occur at any age, but it is most common among young and middle-aged people . Both sexes are equally affected. Several environmental factors have been suggested as triggering Alopecia Areata, including infection, drugs, trauma, and stress. Thyroid autoimmune disease, atopy, and vitiligo are commonly associated. Diverse physical or psychological insults may trigger the episodes of Alopecia Areata, but there is no evidence that they influence prognosis.
Etiology of Alopecia Areata is not completely understood, and the majority of evidence suggests that genetically predisposed individuals, when exposed to an unknown trigger, develop a predominantly autoimmune reaction, leading to acute hair loss.
Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease .
Topical corticosteroids are often the first line of treatment for mild patchy alopecia, with the underlying mechanism being containment of inflammation and hastening of the recovery of damaged hair follicles . Additionally, corticosteroids may be delivered via intralesional injection with slightly better effects (63% with complete regrowth within 4 months in one study . However, this method cannot be used for rapidly progressing variants and does not prevent hair loss at other sites . Furthermore, both topical and intralesional steroids increase the risk of cutaneous atrophy at the site of treatment, and intralesional steroids may decrease bone mineral density .
With the development of new technologies, more and more lasers or lamps have been used to treat alopecia, such as ultraviolet , Excimer laser/lamp , low-level laser , erbium-glass laser, thulium laser , and carbon dioxide laser . Individual researchers have been considering 308-nm Excimer lamp to be used for treating Alopecia Areata by inducing apoptosis of T lymphocytes, but the effective rates had differences in studies .
Excimer laser using high-dose monochromatic UV radiation can trigger apoptosis and induce immunological suppression through altering cytokine production such as interleukin-4, interleukin-10, prostaglandin E2, platelet-activating factor, and cis-urocanic acid .
- Conditions
- Alopecia Areata
- Being tested
- topical steroid and 308nm-Excimer light therapy
- 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 steroid and 308nm-Excimer light therapyCombination product
applying topical steroid in combination with 308nm-Excimer light therapy to treat Alopecia Areata
| Study group | Role | What they receive |
|---|---|---|
| light therapy twice weekly | Active comparator | 15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light twice weekly and topical steroid twice daily the second patch will be treated by topical steroid twice daily. the third patch will be left as a control. Receives: Combination Product: topical steroid and 308nm-Excimer light therapy |
| light therapy once weekly | Active comparator | 15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light once weekly and topical steroid twice daily.
the second patch will be treated by topical steroid twice daily. the third patch will be left as a control. Receives: Combination Product: topical steroid and 308nm-Excimer light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of ALopecia Tool score
The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40 percent (0.40), right side = 18 percent (0.18), left side = 18 percent (0.18) and the posterior aspect = 24 percent (0.24). Percentage of hair loss in any of the four areas was multiplied by the percentage of the scalp covered in that area. The Severity of Alopecia Tool score is the sum of the percentage of hair loss in all the areas mentioned above.[10]
Measured: 9months
digital photographs
using identical camera settings, lighting, patient positioning and background.
Measured: 9months
The hair regrowth in the patches of alopecia
0 = no hair regrowth,
- = 1-25percent hair regrowth,
- = 26-50percent hair regrowth,
- = 51-75percent hair regrowth, and
- = 76-100 percent hair regrowth.
Measured: 9months
Dermoscopic evaluation
Dermoscopy will be used to analyze the change in the count of hair at intervals of 4 weeks. The number of hair (total, vellus, and terminal hairs) will be calculated by dermoscopy .
Measured: 9months
A patient satisfaction score
0 to 25percent change = not satisfied, 26 to 50percent = mildly satisfied, 51 to 75percent = moderately satisfied, 76 to 100percent = very satisfied
Measured: 9months
adverse effects
Any encountered adverse effects in terms of pain, erythema, edema and crusts will be recorded.
Measured: 9months
dermoscopic evaluation
The mean diameter of hair will be recorded for analysis.
Measured: 9months
dermoscopic evaluation
diameter of hair will be measured
Measured: 9months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients with three patches of Alopecia Areata the first patch will be treated by topical steroid and Excimer light the second patch will be treated by topical steroid only the third patch will be left as a control
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma magdy zidan taraaf, Assiut University
- Investigators
- Fatma m zidan, student, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793945
- Sponsor's protocol ID
- fmztaraaf
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.
PubMed 28300084Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014 Apr;134(4):1141-1142. doi: 10.1038/jid.2013.464. Epub 2013 Nov 11. No abstract available.
PubMed 24202232Villasante Fricke AC, Miteva M. Epidemiology and burden of alopecia areata: a systematic review. Clin Cosmet Investig Dermatol. 2015 Jul 24;8:397-403. doi: 10.2147/CCID.S53985. eCollection 2015.
PubMed 26244028Hordinsky MK. Overview of alopecia areata. J Investig Dermatol Symp Proc. 2013 Dec;16(1):S13-5. doi: 10.1038/jidsymp.2013.4.
PubMed 24326541Girman CJ, Hartmaier S, Roberts J, Bergfeld W, Waldstreicher J. Patient-perceived importance of negative effects of androgenetic alopecia in women. J Womens Health Gend Based Med. 1999 Oct;8(8):1091-5. doi: 10.1089/jwh.1.1999.8.1091.
PubMed 10565667Wells PA, Willmoth T, Russell RJ. Does fortune favour the bald? Psychological correlates of hair loss in males. Br J Psychol. 1995 Aug;86 ( Pt 3):337-44. doi: 10.1111/j.2044-8295.1995.tb02756.x.
PubMed 7551645Al Hamzawi NK. Evaluation of the Efficacy and Safety of 308-nm Monochromatic Excimer Lamp in the Treatment of Resistant Alopecia Areata. Int J Trichology. 2019 Sep-Oct;11(5):199-206. doi: 10.4103/ijt.ijt_74_19.
PubMed 31728102McElwee KJ, Gilhar A, Tobin DJ, Ramot Y, Sundberg JP, Nakamura M, Bertolini M, Inui S, Tokura Y, King LE Jr, Duque-Estrada B, Tosti A, Keren A, Itami S, Shoenfeld Y, Zlotogorski A, Paus R. What causes alopecia areata? Exp Dermatol. 2013 Sep;22(9):609-26. doi: 10.1111/exd.12209.
PubMed 23947678Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D, Duvic M, King LE Jr, McMichael AJ, Randall VA, Turner ML, Sperling L, Whiting DA, Norris D; National Alopecia Areata Foundation. Alopecia areata investigational assessment guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004 Sep;51(3):440-7. doi: 10.1016/j.jaad.2003.09.032. No abstract available.
PubMed 15337988Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladden M. British Association of Dermatologists' guidelines for the management of alopecia areata 2012. Br J Dermatol. 2012 May;166(5):916-26. doi: 10.1111/j.1365-2133.2012.10955.x. No abstract available.
PubMed 2252439712. Kranseler, J. S. & Sidbury, R. 2017. Alopecia Areata: Update on Management. Indian Journal of Paediatric Dermatology, 18, 261.
Charuwichitratana S, Wattanakrai P, Tanrattanakorn S. Randomized double-blind placebo-controlled trial in the treatment of alopecia areata with 0.25% desoximetasone cream. Arch Dermatol. 2000 Oct;136(10):1276-7. doi: 10.1001/archderm.136.10.1276. No abstract available.
PubMed 11030789Kubeyinje EP. Intralesional triamcinolone acetonide in alopecia areata amongst 62 Saudi Arabs. East Afr Med J. 1994 Oct;71(10):674-5.
PubMed 7821250Samrao A, Fu JM, Harris ST, Price VH. Bone mineral density in patients with alopecia areata treated with long-term intralesional corticosteroids. J Drugs Dermatol. 2013 Feb;12(2):e36-40.
PubMed 23377403Herz-Ruelas ME, Welsh O, Gomez-Flores M, Welsh E, Miranda-Maldonado I, Ocampo-Candiani J. Ultraviolet A-1 phototherapy as an alternative for resistant alopecia areata. Int J Dermatol. 2015 Oct;54(10):e445-7. doi: 10.1111/ijd.13054. No abstract available.
PubMed 26394604
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Combining 308 Nm-Excimer Light and Topical Steroid in the Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT04793945
- Acronym / sponsor ID
- fmztaraaf
- Conditions
- Alopecia Areata
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 11 Mar 2021 (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.
Alopecia areata is a polygenic autoimmune disease causing hair loss, particularly during the anagen phase of hair growth This condition has a lifetime risk of about 2.1% of the world population and the cumulative incidence seems to rise linearly with age .
Patchy non scarring hair loss on the scalp is the most common clinical presentation, although it can also occur elsewhere . In addition to patchy Alopecia Areata , a more severe form, alopecia totalis , presents with diffuse hair loss across the scalp. In the most severe form, alopecia universalis , hair loss occurs on all areas of the body, including the beard, eyelashes, and extremities .
Detailed description
Alopecia Areata can have a large impact on patients' quality of life, causing both cosmetic and psychosocial distress. Studies on the impact of hair loss have shown high levels of self-consciousness, jealousy, embarrassment, depression, introversion, and decreased self-esteem .
Alopecia Areata can occur at any age, but it is most common among young and middle-aged people . Both sexes are equally affected. Several environmental factors have been suggested as triggering Alopecia Areata, including infection, drugs, trauma, and stress. Thyroid autoimmune disease, atopy, and vitiligo are commonly associated. Diverse physical or psychological insults may trigger the episodes of Alopecia Areata, but there is no evidence that they influence prognosis.
Etiology of Alopecia Areata is not completely understood, and the majority of evidence suggests that genetically predisposed individuals, when exposed to an unknown trigger, develop a predominantly autoimmune reaction, leading to acute hair loss.
Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease .
Topical corticosteroids are often the first line of treatment for mild patchy alopecia, with the underlying mechanism being containment of inflammation and hastening of the recovery of damaged hair follicles . Additionally, corticosteroids may be delivered via intralesional injection with slightly better effects (63% with complete regrowth within 4 months in one study . However, this method cannot be used for rapidly progressing variants and does not prevent hair loss at other sites . Furthermore, both topical and intralesional steroids increase the risk of cutaneous atrophy at the site of treatment, and intralesional steroids may decrease bone mineral density .
With the development of new technologies, more and more lasers or lamps have been used to treat alopecia, such as ultraviolet , Excimer laser/lamp , low-level laser , erbium-glass laser, thulium laser , and carbon dioxide laser . Individual researchers have been considering 308-nm Excimer lamp to be used for treating Alopecia Areata by inducing apoptosis of T lymphocytes, but the effective rates had differences in studies .
Excimer laser using high-dose monochromatic UV radiation can trigger apoptosis and induce immunological suppression through altering cytokine production such as interleukin-4, interleukin-10, prostaglandin E2, platelet-activating factor, and cis-urocanic acid .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients with three patches of Alopecia Areata the first patch will be treated by topical steroid and Excimer light the second patch will be treated by topical steroid only the third patch will be left as a control
| Arm | Type | Receives |
|---|---|---|
| light therapy twice weekly | Active comparator | Combination Product: topical steroid and 308nm-Excimer light therapy15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light twice weekly and topical steroid twice daily the second patch will be treated by topical steroid twice daily. the third patch will be left as a control. |
| light therapy once weekly | Active comparator | Combination Product: topical steroid and 308nm-Excimer light therapy15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light once weekly and topical steroid twice daily. the second patch will be treated by topical steroid twice daily. the third patch will be left as a control. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- aged 16-40 years,
- Good general health,
- A clinical diagnosis of multiple Alopecia Areata of the scalp.
- Hair loss <25 percent of the total scalp.
- No use of drugs or hair care products influencing hair growth in the last 2 months.
Key exclusion criteria (6 listed)
- Other causes of hair loss (like endocrine or immunological diseases).
- Skin disease in the treatment area.
- Pregnant or lactating patients.
- Hair transplantation history.
- Photosensitivity history.
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 steroid and 308nm-Excimer light therapyapplying topical steroid in combination with 308nm-Excimer light therapy to treat Alopecia Areata | Combination product | light therapy once weekly, light therapy twice weekly |
Primary outcome
Severity of ALopecia Tool score
Time frame: 9months
The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40 percent (0.40), right side = 18 percent (0.18), left side = 18 percent (0.18) and the posterior aspect = 24 percent (0.24). Percentage of hair loss in any of the four areas was multiplied by the percentage of the scalp covered in that area. The Severity of Alopecia Tool score is the sum of the percentage of hair loss in all the areas mentioned above.[10]
digital photographs
Time frame: 9months
using identical camera settings, lighting, patient positioning and background.
The hair regrowth in the patches of alopecia
Time frame: 9months
0 = no hair regrowth, 1. = 1-25percent hair regrowth, 2. = 26-50percent hair regrowth, 3. = 51-75percent hair regrowth, and 4. = 76-100 percent hair regrowth.
Dermoscopic evaluation
Time frame: 9months
Dermoscopy will be used to analyze the change in the count of hair at intervals of 4 weeks. The number of hair (total, vellus, and terminal hairs) will be calculated by dermoscopy .
A patient satisfaction score
Time frame: 9months
0 to 25percent change = not satisfied, 26 to 50percent = mildly satisfied, 51 to 75percent = moderately satisfied, 76 to 100percent = very satisfied
adverse effects
Time frame: 9months
Any encountered adverse effects in terms of pain, erythema, edema and crusts will be recorded.
dermoscopic evaluation
Time frame: 9months
The mean diameter of hair will be recorded for analysis.
dermoscopic evaluation
Time frame: 9months
diameter of hair will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 28300084Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.
- Background: PubMed 24202232Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014 Apr;134(4):1141-1142. doi: 10.1038/jid.2013.464. Epub 2013 Nov 11. No abstract available.
- Background: PubMed 26244028Villasante Fricke AC, Miteva M. Epidemiology and burden of alopecia areata: a systematic review. Clin Cosmet Investig Dermatol. 2015 Jul 24;8:397-403. doi: 10.2147/CCID.S53985. eCollection 2015.
- Background: PubMed 24326541Hordinsky MK. Overview of alopecia areata. J Investig Dermatol Symp Proc. 2013 Dec;16(1):S13-5. doi: 10.1038/jidsymp.2013.4.
- Background: PubMed 10565667Girman CJ, Hartmaier S, Roberts J, Bergfeld W, Waldstreicher J. Patient-perceived importance of negative effects of androgenetic alopecia in women. J Womens Health Gend Based Med. 1999 Oct;8(8):1091-5. doi: 10.1089/jwh.1.1999.8.1091.
- Background: PubMed 7551645Wells PA, Willmoth T, Russell RJ. Does fortune favour the bald? Psychological correlates of hair loss in males. Br J Psychol. 1995 Aug;86 ( Pt 3):337-44. doi: 10.1111/j.2044-8295.1995.tb02756.x.
- Background: PubMed 31728102Al Hamzawi NK. Evaluation of the Efficacy and Safety of 308-nm Monochromatic Excimer Lamp in the Treatment of Resistant Alopecia Areata. Int J Trichology. 2019 Sep-Oct;11(5):199-206. doi: 10.4103/ijt.ijt_74_19.
- Background: PubMed 23947678McElwee KJ, Gilhar A, Tobin DJ, Ramot Y, Sundberg JP, Nakamura M, Bertolini M, Inui S, Tokura Y, King LE Jr, Duque-Estrada B, Tosti A, Keren A, Itami S, Shoenfeld Y, Zlotogorski A, Paus R. What causes alopecia areata? Exp Dermatol. 2013 Sep;22(9):609-26. doi: 10.1111/exd.12209.
- Background: PubMed 15337988Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D, Duvic M, King LE Jr, McMichael AJ, Randall VA, Turner ML, Sperling L, Whiting DA, Norris D; National Alopecia Areata Foundation. Alopecia areata investigational assessment guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004 Sep;51(3):440-7. doi: 10.1016/j.jaad.2003.09.032. No abstract available.
- Background: PubMed 22524397Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladden M. British Association of Dermatologists' guidelines for the management of alopecia areata 2012. Br J Dermatol. 2012 May;166(5):916-26. doi: 10.1111/j.1365-2133.2012.10955.x. No abstract available.
- Background12. Kranseler, J. S. & Sidbury, R. 2017. Alopecia Areata: Update on Management. Indian Journal of Paediatric Dermatology, 18, 261.
- Background: PubMed 11030789Charuwichitratana S, Wattanakrai P, Tanrattanakorn S. Randomized double-blind placebo-controlled trial in the treatment of alopecia areata with 0.25% desoximetasone cream. Arch Dermatol. 2000 Oct;136(10):1276-7. doi: 10.1001/archderm.136.10.1276. No abstract available.
- Individual participant dataSharing planned: Yes
Related trials for Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
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.
Fatma m zidan, student principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing topical steroid and 308nm-Excimer light therapy in people with 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 5 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 11 Mar 2021. 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.
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?
Contact eman R mohamed hofny, professor (01005298992 ext. 002, e_riad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of ALopecia Tool score (time frame: 9months). The study lists 8 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 NCT04793945, which also lists 24 linked publications.
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 11 Mar 2021.