Topical Treatment for Eczema
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: No dermatitis, BSA <2%, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Triamcinolone cream for treating eczema?
Research shows that triamcinolone acetonide, a key ingredient in the cream, is effective in treating various skin conditions, including eczema. In a study comparing it to another steroid cream, triamcinolone was found to be equally effective in improving eczema symptoms.
12345Is Triamcinolone cream safe for use in humans?
Triamcinolone cream, used for various conditions, has been shown to be generally safe in humans. Some side effects like weight gain, changes in menstruation, and increased blood pressure have been reported, but they are not common. In studies, adverse effects were usually mild and occurred at the application site.
12367Eligibility Criteria
This trial is for individuals with atopic dermatitis, commonly known as eczema. It's designed to help those who struggle with following their medication regimen consistently.Inclusion Criteria
I have been diagnosed with skin dermatitis.
I am older than 9 years.
Ability to return for a one-week clinical studies follow-up
+2 more
Exclusion Criteria
I do not have skin dermatitis.
Less than 2% of my body is affected by my condition.
I cannot come back for a follow-up in one week.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive topical treatment with triamcinolone cream, with different groups receiving varying levels of instruction on application
1 week
1 visit (in-person)
Follow-up
Participants are monitored for changes in body surface area affected and other measures after treatment
1 week
1 visit (in-person)
Participant Groups
The study is testing the effectiveness of a mobile app in improving treatment adherence compared to standard care. Participants will also be shown how to apply triamcinolone cream properly.
3Treatment groups
Experimental Treatment
Active Control
Group I: Written/verbal instructions onlyExperimental Treatment1 Intervention
Standard of care written/verbal instructions only
Group II: Mobile ApplicationExperimental Treatment1 Intervention
Additional mobile application that provides instructions to apply the medication (triamcinolone cream)
Group III: DemonstrationActive Control1 Intervention
Observe a live demonstration instructing how to dispense 1 fingertip unit (FTU) of medication (triamcinolone cream) per 1% body surface area
Triamcinolone cream is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Triamcinolone cream for:
- Atopic dermatitis
- Eczema
- Psoriasis
- Contact dermatitis
- Seborrheic dermatitis
🇪🇺 Approved in European Union as Triamcinolone cream for:
- Atopic dermatitis
- Eczema
- Psoriasis
- Contact dermatitis
- Seborrheic dermatitis
🇨🇦 Approved in Canada as Triamcinolone cream for:
- Atopic dermatitis
- Eczema
- Psoriasis
- Contact dermatitis
- Seborrheic dermatitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health SciencesWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
References
Efficacy of bufexamac (NFN) cream in skin diseases. A double-blind multicentre trial. [2019]The effect of a new non-steroid anti-inflammatory substance (bufexamac) in a special constituent was compared with that of 0.1% triamcinolone acetonide, 1% hydrocortisone cream, and placebo during a double-blind multicentre trial. The clinical effect of these four creams was studied in 193 patients receiving treatment for the following skin disorders: atopic dermatitis, allergic contact dermatitis, and non-allergic contact dermatitis, as well as dermatitis seborrheica. After 2 and 4 weeks' treatment, when 193 and 157 patients, respectively, were re-examined, the effect of triamcinolone acetonide and hydrocortisone cream was significantly better, than that obtained with bufexamac in the cream basis employed. On the other hand, no statistically significant difference in effect between bufexamac and placebo cream was observed.
The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]A group of 145 patients with severe intrinsic bronchial asthma symptoms was treated with repeated intramuscular injections of triamcinolone acetonide (Kenalog) during an average period of two years. Kenalog was administered mainly to persons with persistent attacks of asthmatic dyspnea and frequent recurrent infections of the respiratory tract in which other drugs, including orally administered steroids, did not lead to any improvement in the asthmatic symptoms. The results of therapy were excellent (total disappearance of asthmatic manifestations) or good (considerable improvement of asthma symptoms) in 88.3% of treated cases, while in 11.7% of patients, Kenalog had no effect. In 13.8% of cases, side effects, especially weight gain, disturbances in menstruation, increase in blood pressure, edema and spontaneous echymoses were observed. The triamcinolone acetonide depot-preparation is, in the authors' opinion, highly effective in the management of severe intrinsic asthma cases, unsucessfully treated by other methods. The prolonged use of Kenalog can, however, like other steroids provoke, several side effects.
Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. [2020]Intralesional Kenalog (triamcinolone) injection is a useful treatment for several skin conditions. Although dermal deposition of triamcinolone has been described in the literature, histopathologic findings of foreign body reactions to it have seldom been reported. Here, we describe a case of a granulomatous reaction to the intralesional injection of triamcinolone acetonide in the treatment of nodulocystic acne.
A double-blind controlled trial of betamethasone dipropionate 0.05% (Diproderm) in comparison with fluocinolone acetonide 0.025% (Synalar) in psoriasis and other steroid-responsive dermatoses. [2017]In a double-blind randomized study, sixty-two patients suffering from psoriasis or eczema were treated, twice daily for three weeks, either with 0.05% betamethasone 17, 21-dipropionate cream or with 0.025% fluocinolone acetonide cream. The results showed that both topical corticosteroid preparations were effective, well tolerated and cosmetically acceptable. Fifty-seven per cent of the patients treated with betamethasone dipropionate were rated as being 'much better' in the overall assessment of response at the end of the trial period compared to only 25% of those in the fluocinolone acetonide group.
Topical treatment of eczema with triamcinolone acetonide benzoyl-beta-amino-isobutyrate: a double-blind comparison with betamethasone dipropionate. [2017]The results are reported of a double-blind study of the topical efficacy of triamcinolone acetonide benzoyl-beta-amino-isobutyrate (TBI), in 21 patients with symmetrically paired lesions of acute eczema. The effects were compared with those of betamethasone dipropionate. On the indication chosen, the two corticosteroids were equally efficacious; tolerance, also, was the same for both substances.
A comprehensive review of the long-term and short-term treatment of melasma with a triple combination cream. [2018]Melasma is a common disorder of hyperpigmentation and generally involves areas of the face and neck. Hyperpigmentation is especially prevalent in darker complected patients and is often difficult to treat. Hydroquinone, tretinoin, and topical corticosteroids are well established monotherapeutic agents for treating melasma and hyperpigmentation; however, a stable, once-daily formulation triple combination cream containing 0.05% tretinoin, 4.0% hydroquinone, and 0.01% fluocinolone acetonide (Tri-Luma) represents the only commercially available combination of all three agents. This product is approved by the US FDA for the treatment of facial melasma. A number of publications have described the safety and efficacy of triple combination cream in over 2000 patients with melasma, some of whom were treated for >12 months. In the initial 8-week study, 29% of patients experienced complete clearing of melasma by week 8, and 77% were clear or almost clear by week 8. Similarly, good results were seen in the two long-term studies, with the clear/mild rate ranging from 78% to 84% of patients at month 6 and from 81% to 94% of patients at month 12. Adverse events were almost always mild in severity and typically occurred only at the application site. The primary concern for most physicians using corticosteroid-containing products on the face is skin atrophy. However, only two cases of skin atrophy were reported across the three published studies. Overall, the results of these extensive studies indicate that triple combination cream is efficacious in treating melasma and exhibits a safe profile with low potential for adverse events.
Low-dose triamcinolone acetonide in the phytocosmetic lichtena reduces inflammation in mild to moderate atopic dermatitis. [2013]Previously, we reported the efficacy of Lichtena--a phytocosmetic cream product--in atopic dermatitis (AD). Later, fraudulent triamcinolone acetonide (TACA) was detected at low doses (16-40 microg/g) in Lichtena. This suggested that TACA may be effective at much lower concentrations than used in commercial products (1,000 microg/g).
A comparative trial of Clinitar versus hydrocortisone cream in the treatment of atopic eczema. [2019]Thirty patients with mild to moderate bilateral atopic eczema were treated on one side of the body with a new purified coal tar cream (Clinitar) and on the other side with 1% hydrocortisone cream, for 4 weeks. The degree of infiltration of the skin erythema, lichenification, excoriations and dryness were assessed. Both treatments were equally effective in reducing symptoms and there was also no difference in patient preference and cosmetic acceptability.
Pimecrolimus cream in the management of patients with atopic eczema. [2021]Atopic eczema is a common pediatric skin disorder. This review examines the use of pimecrolimus cream in the treatment of acute and chronic stages of the disease. The standard therapy is the treatment of acute flares with topical medications including pimecrolimus. The use of pimecrolimus cream for the first sign and symptoms of atopic eczema reduces the occurrence of flares as defined by the need for topical corticosteroids. The side effects of pimecrolimus cream are mild without any increase of infections or systemic immune suppression.