Excimer Light and Topical Steroid in Treatment of Alopecia Areata
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| ClinicalTrials.gov Identifier: NCT04793945 |
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Recruitment Status :
Not yet recruiting
First Posted : March 11, 2021
Last Update Posted : March 11, 2021
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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 .
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alopecia Areata | Combination Product: topical steroid and 308nm-Excimer light therapy | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| Official Title: | The Efficacy of Combining 308 Nm-Excimer Light and Topical Steroid in the Treatment of Alopecia Areata |
| Estimated Study Start Date : | April 1, 2021 |
| Estimated Primary Completion Date : | April 1, 2022 |
| Estimated Study Completion Date : | September 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: light therapy twice weekly
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.
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Combination Product: topical steroid and 308nm-Excimer light therapy
applying topical steroid in combination with 308nm-Excimer light therapy to treat Alopecia Areata |
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Active Comparator: light therapy once weekly
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. |
Combination Product: topical steroid and 308nm-Excimer light therapy
applying topical steroid in combination with 308nm-Excimer light therapy to treat Alopecia Areata |
- 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,
- = 1-25percent hair regrowth,
- = 26-50percent hair regrowth,
- = 51-75percent hair regrowth, and
- = 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
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| Ages Eligible for Study: | 16 Years to 40 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793945
| Contact: eman R mohamed hofny, professor | 01005298992 ext 002 | e_riad@yahoo.com | |
| Contact: yasmeen M tawfik mhany, PHD | 01006033331 ext 002 | dr.yasminmostawfik@yahoo.com |
| Principal Investigator: | Fatma m zidan, student | Assiut University |
| Responsible Party: | fatma magdy zidan taraaf, principle investigator, Assiut University |
| ClinicalTrials.gov Identifier: | NCT04793945 |
| Other Study ID Numbers: |
fmztaraaf |
| First Posted: | March 11, 2021 Key Record Dates |
| Last Update Posted: | March 11, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | one year |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |