Results of clinical trial of E5166 for skin diseases: an analysis by open study.

The skin is one of the crucial body organs with anatomy and physiology linked to various disorders including congenital and acquired diseases. Nowadays, mesenchymal stem cell (MSCs)- based therapy has appeared as a promising therapeutic field, in which many see opportunities to cure the costliest and incurable diseases. However, one question to be asked is that if the use of MSCs in clinical trials studies and diseases treatment has improved. In this study, the clinical trials using MSCs in skin diseases were reviewed. A remarkable number of clinical trial studies are in progress in this field; however, only a few of them have led to tangible benefits for patients. The relevant papers and ongoing clinical trials that address MSC’s therapeutic goals for various skin disorders were examined. This review can be very useful for both the dermatologists and basic skin researchers interested in contributing to stem cell-based therapeutic researches in the area of skin disorders.

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Homoeopathic treatment of malaria in Ghana

British Homeopathic Journal ◽

10.1016/s0007-0785(96)80178-5 ◽

1996 ◽

Vol 85 (02) ◽

pp. 66-70 ◽

Cited By ~ 6

Author(s):

Veronique M.A. Van Erp ◽

Martien Brands

Keyword(s):

Clinical Trial ◽

Clinical Improvement ◽

Open Study ◽

Northern Region ◽

The Other ◽

Double Blind ◽

Double Blind Clinical Trial

AbstractIn a clinic in Tamale (Ghana, Northern Region) patients with malaria were treated with homoeopathic drugs in an open study (n=75), of whom 90.7% (n=68) showed clinical improvement.Subsequently in a randomized, double-blind, clinical trial, one group (n=30) received homoeopathic drugs, of which 83.3% improved clinically, whereas the other group (n=25) received chloroquine with improvement in 72% patients. This difference is not statistically significant due to the limited samples. The results do, however, suggest further research with larger groups.

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Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial

Trials ◽

10.1186/s13063-021-05428-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Kristin Helene Skullerud ◽

Petter Gjersvik ◽

Are Hugo Pripp ◽

Erik Qvigstad ◽

Anne Lise Ording Helgesen

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Lichen Planus ◽

Global Assessment ◽

Skin Diseases ◽

Inflammatory Skin Diseases ◽

Erosive Lichen Planus ◽

The Mean ◽

Inflammatory Skin

Abstract Background Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal erosions and scarring, often resulting in poor sexual health and reduced quality of life. Treatment options are limited and often with little effect. Apremilast, a phosphodiesterase 4-inhibitor, has been shown to have a positive effect on psoriasis and other inflammatory skin diseases. We aim to investigate the effect and safety of peroral apremilast in women with GELP in a randomised placebo-controlled double-blinded clinical trial. Methods We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a specialised vulva clinic in Oslo, Norway. The patients will be randomised 1:1 to either apremilast 30 mg BID (with an initial dose titration on days 1–6) or a placebo for 24 weeks. The concomitant use of topical corticosteroids will be allowed. The primary end point will be the mean GELP score, a clinical scoring system, at week 24 in the apremilast-treated patients versus the placebo-treated patients. The secondary end points will include the mean GELP score improvement from weeks 0 to 24, patient-reported use of topical steroids, the pain score on a visual analogue scale and the number of patients with GELP score improvements at weeks 16 and 24. The Physician Global Assessment , Patient Global Assessment and selected quality of life and sexual function assessments will be recorded at weeks 0, 16 and 24. The exploratory endpoints include description of immunohistochemical changes before and after apremilast therapy, assessed in vulvar or vaginal biopsies at weeks 0 and 24. Regular follow-ups for possible adverse events will be conducted. Discussion The study design is based on experience from studies on apremilast in other inflammatory skin diseases using equivalent apremilast doses for approved indications. The trial may provide evidence for the use of apremilast in women with this burdensome genital dermatosis. Trial registration ClinicalTrials.govNCT0365666. Registered on 4 September 2018.

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CLINICAL TRIAL TO EVALUATE AN EFFICACY OF SHINSHAPATWAK GHAN-VATI IN THE MANAGEMENT OF GRUDHRASI (SCIATICA)

November 2020 - International Ayurvedic Medical Journal ◽

10.46607/iamj1008082020 ◽

2020 ◽

Vol 8 (8) ◽

pp. 4090-4097

Author(s):

Devyani Shinde ◽

Purti Barhate ◽

Pawan Rane ◽

Sonam Kanzode

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Open Study ◽

Daily Life ◽

Radicular Pain ◽

Human Being ◽

Low Back ◽

Common Disorder ◽

Treatment Improvement

Introduction: A normal daily life without moving the limbs is almost impossible for any human being from the time immemorial to ultramodern life. Though the movements of the limbs are so important, these are the parts frequently vulnerable to many diseases. The most common disorder which affects the move-ments of the leg is low back pain, out of which 40% of persons will have radicular pain which comes un-der sciatic syndrome. Such presentation’s been present in olden period too and was called by the name Grudhrasi. Material & Method: An Open study with Shinshipatwak Ghanavati with Dugdha Anupana was done in 30 patients of Grudhrasi. Result: In total score it was found that after finishing treatment, improvement of 79.39% observed. Result was statistically highly significant after 21 days (P<0.001). Shinshipatwak yoga was more effective in Kaphanubandhit Grudhrasi.

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Ablative fractional laser improves treatment of actinic keratoses with Ingenol Mebutate

European Journal of Inflammation ◽

10.1177/1721727x16674219 ◽

2016 ◽

Vol 14 (3) ◽

pp. 200-205 ◽

Cited By ~ 2

Author(s):

Steven Nisticò ◽

Mario Sannino ◽

Ester Del Duca ◽

Federica Tamburi ◽

Ugo Bottoni ◽

...

Keyword(s):

Open Study ◽

Skin Diseases ◽

Therapeutic Option ◽

Ingenol Mebutate ◽

Fractional Laser ◽

Treatment Area ◽

Actinic Keratoses ◽

Ablative Fractional Laser ◽

Efficacy Profile

Actinic keratoses (AK) are pre-neoplastic lesions related to an excessive ultraviolet exposure that represent an emerging issue in the area of skin diseases which undergo high risk for developing squamous cell carcinoma (SCC). In this open study, we tested the safety efficacy profile of sequential ablative laser and Ingenol Mebutate gel (IngMeb). Thirteen patients with a total of 99 lesions were selected for this open study. When multiple lesions on the same area were found, the treatment area was split in half. In one group, fractional CO2 laser microablative treatment was performed the day before three daily applications of IngMeb 150 lg/g; the other group received IngMeb without previous laser ablation. Fifty-six lesions were treated with laser and IngMeb and a total of 43 lesions in the second group were treated with IngMeb alone. Results at the 12-week follow-up visit showed that a clearance rate of 50/56 (89.2%) had been achieved. On the side that was not pre-treated with laser, 31 out of 43 lesions were cleared (72.1%). In our opinion, ablative fractional laser treatment could improve topical treatment of AKs, or provide a further therapeutic option for resistant patients.

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Clinical trial design for cutaneous neurofibromas

Neurology ◽

10.1212/wnl.0000000000005790 ◽

2018 ◽

Vol 91 (2 Supplement 1) ◽

pp. S31-S37 ◽

Cited By ~ 5

Author(s):

Ashley Cannon ◽

Kurt Jarnagin ◽

Bruce Korf ◽

Brigitte C. Widemann ◽

Denise Casey ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Trial Design ◽

Skin Diseases ◽

Clinical Trial Design ◽

Patient Reported Outcome ◽

Clinical Development ◽

Patient Reported ◽

Intervention Patient ◽

Cutaneous Neurofibromas

ObjectiveSeveral clinical trials targeting cutaneous neurofibromas (cNF) have been conducted; however, none has resulted in meaningful changes to care. The Clinical Trial Design and Development subgroup's goals were to (1) define key considerations in the design of clinical trials for cNF, (2) summarize existing data in relation to these considerations, and (3) provide consensus recommendations about key elements of trial design to accelerate the clinical development of therapies for cNF.MethodsThe subgroup, with experts from genetics, dermatology, neurology, oncology, and basic science, spanning academia, government research, and regulatory programs, and industry, reviewed published and unpublished data on clinical trials for cNF and other diseases in the skin. Discussions of these data resulted in formulation of a list of priority issues to address in order to develop efficient and effective clinical trials for cNF.ResultsThe subgroup identified 2 natural history studies of cNF, 4 priority outcome measures, and 6 patient-reported outcome tools for potential use in efficacy trials of cNF. Time to initiate intervention, patient eligibility, mechanism of action, route of administration, safety monitoring, and regulatory agency interactions were identified as key factors to consider when designing clinical trials for cNF.ConclusionsAlignment on endpoints and methods for the measurement and quantification of cNF represent a priority for therapeutic development for cNF. Advances in technological methods and outcome tools utilized in other skin diseases may be applicable to cNF studies. Patient age is an important factor guiding trial design and clinical development path.

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Role of Virechana Purvaka Shamana Sneha with Rasayana drugs in the management of Psoriasis (Ekakustha).

Journal of Ayurveda and Integrated Medical Sciences (JAIMS) ◽

10.21760/jaims.v2i1.7482 ◽

2017 ◽

Vol 2 (1) ◽

Author(s):

Sweety J. Ruparel ◽

Sudhaben Vyas

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Skin Diseases ◽

Social Stigma ◽

Medical Science ◽

Radical Cure ◽

Temporary Relief ◽

Therapeutic Measures ◽

Chronic Course

Skin diseases are taken up as a social stigma, due to altered appearance. Psoriasis is one of the most repulsive skin diseases which may disturb patient’s life. It usually runs a chronic course with remission and exacerbations. As far as treatment is concerned modern medical science has number of therapeutic measures which provide temporary relief accompanied by side effects and which make the patients to take lifelong treatment. So it is a need to find out an effective radical cure for psoriasis through Ayurveda. According to Ayurveda all skin diseases are taken under generalized term Kustha. In present study psoriasis is considered as Ekakustha, one type of Kshudrakustha. As Shodhana therapy is essential in the management of all skin diseases, Virechana Karma was selected because it is the only procedure which acts upon all three Doshas and Raktadi Dushyas which are vitiated in Kustha. After Virechana Karma, Shamana treatment was also given to alleviate remaining Doshas and to continue the normal state of Dhatus. This clinical trial was conducted on total 13 patients of psoriasis (Ekakustha) to compare the effect of Virechana Purvaka Shamana with only Shamana. For Shamana purpose Shamana Sneha (Panchatikta Ghrita) along with some Rasayana drugs were used. Duration of Shamana treatment was 2 months in both groups. Patients of both the groups showed significant results. But Virechana Purvaka Shamana was found to be more effective than only Shamana.

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