Mild to Moderate Atopic DermatitisPhase 2NCT02079688
Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of the Topical Formulation SB011 Applied to Lesional Skin in Patients With Atopic Eczema
A Phase 2 study testing SB011, 2 % (Water/Oil/Water) emulsion of hgd40 in people with Mild to Moderate Atopic Dermatitis, run by Sterna Biologicals GmbH & Co. KG at 1 site in Germany.
Trial summary
Atopic dermatitis (AD) is a chronic or chronic recurring inflammatory skin disorder. Patients suffer from eczema and often severe pruritus on the affected skin, as well as from frequent complications and secondary infections. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Mild to Moderate Atopic Dermatitis
- What is being tested?
- SB011, 2 % (Water/Oil/Water) emulsion of hgd40
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Jan 2017
- Phase
- Phase 2
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient oral and written informed consent
- Adult Caucasian patients (male and female) aged 18-69 years (both included);
- Patients smoking ≤ 10 cigarettes/day
- Patient has confirmed diagnosis of atopic dermatitis using the diagnostic features as described by Hanifin and Rajka, initial diagnosis made at least 12 weeks before first treatment;
- SCORAD (12) between 20 and 50 (mild to moderate atopic dermatitis);
- Two comparable lesional areas of approximately 50 cm2 each (difference in modified local SCORAD not greater than 2) on the arms, legs, chest, stomach or neck (distance between the lesions at least 5 cm), clinical condition of atopic eczema mild to moderate defined by a modified local SCORAD between 7 and 10 with 2 parameters scored at least 2 one being the erythema score;
Show all 15Show fewer
- Patient has to have an increased total IgE;
- Patient has to have an increased specific IgE of at least 1 of the sx1 allergens with CAP classification II [>0.7 KU/l];
- Erythema score from modified local SCORAD for both lesional areas of at least 2;
- TEWL in the lesional areas at least 12 g/m²h, TEWL value differences ≤ 30 % are allowed between both lesional areas (related to the higher TEWL value);
- Except for atopic diseases or asthma like atopic dermatitis or allergic rhinitis assessed as healthy based on a screening examination including medical history, physical examination of the skin, vital signs, and clinical laboratory results;
- The male patient must agree:
- to use two methods of contraception in combination with his female partner, if she is of childbearing potential (At least one of the contraception methods must be a barrier contraception method)
- The female patient must agree:
- to use two methods of contraception in combination with her male partner, if she is of childbearing potential;
Who cannot join
- History of allergic reactions to any active or inactive component of the IMP;
- Presence of clinically significant diseases other than asthma or atopic diseases (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.) which in the opinion of the investigator, influence the results of the trial or the patient's ability to take part in it;
- Inherent or acquired immune deficiency, immune deficiency in consequence of drug use;
- Immune mediated diseases;
- Suntan, hyperpigmentation or tattoos in the test fields;
- Dark-skinned persons whose skin colour prevents ready assessment of skin reactions;
Show all 31Show fewer
- Systemic bacterial or mycotic as well as severe viral systemic infections;
- Severe systemic other disease;
- Patients with a resting heart rate <50 and >100 bpm, systolic blood pressure <100 and >150 mmHg, diastolic blood pressure <60 and >95 mmHg;
- UV-therapy within 6 weeks before first treatment and during the trial;
- History or current evidence of a malignant tumour (an excised basal cell carcinoma distant from target lesion with at least 14 days after surgery will be allowed);
- Clinically relevant abnormalities in serology, clinical chemical, haematological or in any other laboratory variables;
- Chronic or acute infections (a small lesion of non-treated onychomycosis will be allowed in the opinion of the investigator);
- Pregnancy or nursing
- Signs of secondary infections on the lesions to be treated;
- History of previous administration of SB011 or any other registered or investigational oligonucleotide-based drug;
- History or presence of alcohol or drug abuse;
- Consumption of alcohol within 48 h before administration of IMPs and during the trial;
- Use of any medication (including over-the-counter medication such as herbal products) except allowed concomitant medication within 2 weeks (for biologics: 6 months, for systemic treatment of atopic dermatitis 4 weeks) before administration of the IMPs or within <10 times the elimination half-life of the respective drug, or the duration of the pharmacodynamics effect, whatever is longer, or anticipated concomitant medication during the treatment period (exception: asthma may be found in patients with AD, therefore the continuation of inhalative treatment with corticosteroids in patients with asthma accompanying AD that began at least four weeks prior to randomisation will be allowed; dose limited: ≤ 300 μg/d fluticasone propionate or equivalent);
- Treatment with known cytochrome P450 enzyme inducing or inhibiting agents (St. John's Wort ("Johanniskraut"), barbiturates, phenothiazines, cimetidine, ketoconazole) within 30 days before administration of the IMPs or during the trial;
- Consumption of grapefruit, grapefruit juice within 14 days prior to the IMP administration or during the trial;
- Need for additional skin care products in the treatment area(s);
- Use of skin care products with anti-septic components during the last four weeks before first treatment and during the trial or anti-septic textiles with contact to the target lesions;
- Proneness to orthostatic dysregulation, faintings, or blackouts;
- Planned donation of germ cells, blood, organs, bone marrow during the course of the trial or within 6 months thereafter;
- Participation in another clinical trial with an investigational drug or device within the last 3 months. For biologics, the minimum exclusion period is at least 6 months or the time of duration of the pharmacodynamics effect or 10 times the half-life of the respective drug whatever is longer before inclusion in this trial;
- Lack of ability or willingness to give informed consent;
- Anticipated non-availability for trial visits/procedures;
- Anticipated lack of willingness or inability to cooperate adequately;
- Close affiliation with the investigators (e.g. a close relative) or with persons working at bioskin GmbH or with persons working at the study site or with employees of sterna biologicals GmbH \& Co. KG;
- Vulnerable patients (e.g., persons kept in detention)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division for Immunodermatology and Allergy Research Clinic for Dermatology, Allergy and Venereology Hannover Medical School
Hanover, 30625
About this study
Official title: A Phase IIa, Single-centre, Randomised, Vehicle Controlled, Double-blind Trial for Assessment of Efficacy, Safety and Tolerability of the Topical Formulation SB011 Containing a Human GATA-3 Specific DNAzyme and of Systemic Absorption of hgd40 Following Application to Lesional Skin in Patients With Atopic Eczema
Atopic dermatitis (AD) is a chronic or chronic recurring inflammatory skin disorder. Patients suffer from eczema and often severe pruritus on the affected skin, as well as from frequent complications and secondary infections. Next to a genetically predetermined defect in epidermal barrier function and vegetative dysfunction, AD arises from an upregulation of Th2-modified immune responses inducing increased IgE-antibody production, cytokine secretion and subsequently, local inflammation.
Although standard therapies of AD, modern topical corticosteroids, show a better ratio of therapeutic effects to side effects, they retain a moderate acceptance due to their non-specific action, strict compliance requirements and possible adverse effects. As a newer alternative, calcineurin inhibitors show fewer side effects but raise concerns regarding long term risks including the possibility of skin carcinogenicity. Therefore, medical need remains for novel therapies for this major public health problem, directed in particular at specific early disease-causing mechanisms and/or molecular targets, with an improved efficacy, safety and compliance.
Read more
Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting early disease-causing mechanisms are a promising approach for the treatment of AD.
The transcription factor GATA-3 represents the key regulatory factor of Th2-driven immune responses. It is indispensable for the differentiation and activation of Th2 cells; it integrates Th2 signals and induces Th2 cytokine expression. The investigational product SB011 contains the DNAzyme hgd40 that targets GATA-3. By cleaving GATA-3 mRNA hgd40 reduces specific cytokine production and thereby reduces key features of allergic airway inflammation.
DNAzymes are completely generated by chemical synthesis and can be produced under Good Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by use of any living organism including cell culture or bacteria. The molecules are highly water-soluble and will be applied as a water/oil/water (W/O/W) formulation since multiple emulsions have been shown to protect the active ingredient from degradation on the skin and have penetration enhancing properties in comparison to other carrier systems.
This proof-of-concept study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the topical formulation SB011 containing 2 % hgd40 twice daily (BID) in patients with mild to moderate atopic eczema.
- Conditions
- Mild to Moderate Atopic Dermatitis
- Being tested
- SB011, 2 % (Water/Oil/Water) emulsion of hgd40, Multiple W/O/W formulation, active ingredient-free vehicle
- Keywords
- Antisense oligonucleotide, atopic eczema, atopic dermatitis, Phase II, Transcription factor GATA-3, dermal application, Proof-of-Concept
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB011, 2 % (Water/Oil/Water) emulsion of hgd40Drug
Also called Active drug substance is hgd40
Treatment will be performed BID on 14 consecutive days and one single last application at the site on Day 15 (29 applications in total).
Two preferably disseminated and contralateral, comparable lesional treatment areas of approximately 50 cm2 each and located on arms, legs, chest, stomach or neck will be chosen. All patients will perform treatment with both formulation SB011 containing 2% hgd40 and the active ingredient-free vehicle. Comparison of the IMPs will be performed intraindividually.
Approximately 5 mg/cm2 (250 μl) of SB011 (2% hgd40) and the vehicle will be applied to the respective treatment areas. The time between the two applications should include min. 8 hours and max. 16 hours. Patients compliance will be controlled by weighing of the IMPs at each visit. On day 1 the application of the IMPs will be demonstrated to the patients at the clinical site. The first treatment as well as the morning treatment on Days 3, 5, 8, 12, and 15 will be carried out at the clinical site
Multiple W/O/W formulation, active ingredient-free vehicleDrug
Treatment will be performed BID on 14 consecutive days and one single last application at the site on Day 15 (29 applications in total).
Two preferably disseminated and contralateral, comparable lesional treatment areas of approximately 50 cm2 each and located on arms, legs, chest, stomach or neck will be chosen. All patients will perform treatment with both formulation SB011 containing 2% hgd40 and the active ingredient-free vehicle. Comparison of the IMPs will be performed intraindividually.
Approximately 5 mg/cm2 (250 μl) of SB011 (2% hgd40) and the vehicle will be applied to the respective treatment areas. The time between the two applications should include min. 8 hours and max. 16 hours. Patients compliance will be controlled by weighing of the IMPs at each visit. On day 1 the application of the IMPs will be demonstrated to the patients at the clinical site. The first treatment as well as the morning treatment on Days 3, 5, 8, 12, and 15 will be carried out at the clinical site
| Study group | Role | What they receive |
|---|---|---|
| SB011, 2 % (Water/Oil/Water) emulsion of hgd40 | Experimental | All patients will perform treatment with formulation SB011 containing 2 % hgd40 and the active ingredient-free vehicle. The comparison of the IMPs will be performed intraindividually.
Comparison and random assignment of treatments to two distinct treatment areas (area 1, area 2).
IMP SB011: Topical application of approximately 5 mg/cm2 (250 μl) per treatment area (50 cm2) twice daily on 14 consecutive days, one single last application at the site on Day 15 (29 treatments) daily dosage: Approximately 10 mg hgd40 total dosage: Approximately 145 mg hgd40 Receives: Drug: SB011, 2 % (Water/Oil/Water) emulsion of hgd40 |
| Multiple W/O/W formulation, active ingredient-free vehicle | Placebo comparator | All patients will perform treatment with formulation SB011 containing 2 % hgd40 and the active ingredient-free vehicle. The comparison of the IMPs will be performed intraindividually.
Comparison and random assignment of treatments to two distinct treatment areas (Area 1, Area 2).
Vehicle: Topical application of approximately 5 mg/cm2 (250 μl) per treatment area (50 cm2) twice daily on 14 consecutive days, one single last application at the site on Day 15 (29 treatments) Receives: Drug: Multiple W/O/W formulation, active ingredient-free vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of local SCORing atopic dermatitis (SCORAD) from baseline to Day 15.
The following parameters are included in scoring:
A: the extent of the involved body area;
B: the intensity of the criteria erythema, edema/papulation, oozing/crusts, excoriations,lichenification and dryness, whereby dryness is evaluated on uninvolved areas;
C: the subjective symptoms of pruritus at application areas and sleep loss evaluated on a visual analogue scale from 0 to 10 (average for the last three days or nights) and added. The intensity of each of the criteria erythema, edema/papulation, oozing/crusts, excoriations, lichenification and dryness will be graded according to the following 4 point scale:
0 = absent
- = mild
- = moderate
- = severe Each single parameter for SCORAD calculation will be documented on a source document. The SCORAD will be calculated according to the formula A/5 + 7B/2 + C and documented in the source documents and the CRF.
Measured: On baseline (day 1) and on day 15 (Last day after 2 Weeks IMP administration)
Secondary outcomes (11)
The change from baseline in modified local SCORAD
Measured: On Days 3, 5, 8, and 12
Modified local SCORAD
The intensity of each of the criteria will be graded according to the following 4 point scale and documented in the CRF:
0 = absent
- = mild
- = moderate
- = severe
Measured: on Days 1, 3, 5, 8, 12, and 15
Change from baseline in transepidermal water loss (TEWL)
Measured: On Days 3, 5, 8, 12, and 15
TEWL on Days 1, 3, 5, 8, 12, and 15
Measured: Days 1, 3, 5, 8, 12, and 15
Subjective assessment of pruritus using a 10-point rating scale
Subjective assessment of pruritus at test sites on Days 1, 3, 5, 8, 12, and 15 using a 10-point rating scale.
Measured: Days 1, 3, 5, 8, 12, and 15
Subjective efficacy assessment on Days 3, 5, 8, 12 and 15
The efficacy of the IMPs will be assessed in each test area by asking the patients using the following 5-point rating scale: The answer of the patients will be documented in the CRF.
0 = no activity
- = poor
- = fair
- = good
- = excellent
Measured: Days 3, 5, 8, 12 and 15
Subjective dermal tolerability assessment using a 5-point rating scale on Days 3, 5, 8, 12 and 15
The dermal tolerability of the IMPs will be assessed in each test area by asking the patients using the following 5-point rating scale: The answer of the patients will be documented in the CRF.
0 = no activity
- = poor
- = fair
- = good
- = excellent
Measured: Days 3, 5, 8, 12 and 15
Pharmacokinetic outcome measure
The pharmacokinetic endpoints are the hgd40 levels on Days 1 (pre-dose and 1, 2, 4 and 6 h post-dose) and 15 (pre-dose and 1, 2, 4 and 6 h post-dose and 24 h post-dose to Day 15).
Measured: Day 1 and Day 15
Physical examination of the skin and Vital signs
Measured: Screening period and day 16
Adverse Events
Measured: Including the whole screening period and the experimental phase day -14 to day 16
Standard Safety laboratory
Including serology, IgE [immunoglobulin E] and sx1 test at screening
Measured: Screening period + on days 1, 5 and 16 in the Treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sterna Biologicals GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Werfel, Prof. Dr., Principal investigator, Division for Immunodermatology and Allergy Research Clinic for Dermatology, Allergy and Venereology Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079688
- Sponsor's protocol ID
- SB011/02/2013
- Status last verified
- Jan 2017
- First submitted
- 4 Mar 2014
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Single-centre, Randomised, Vehicle Controlled, Double-blind Trial for Assessment of Efficacy, Safety and Tolerability of the Topical Formulation SB011 Containing a Human GATA-3 Specific DNAzyme and of Systemic Absorption of hgd40 Following Application to Lesional Skin in Patients With Atopic Eczema
- ClinicalTrials.gov ID
- NCT02079688
- Acronym / sponsor ID
- SB011/02/2013
- Conditions
- Mild to Moderate Atopic Dermatitis
- Keywords
- Antisense oligonucleotide, atopic eczema, atopic dermatitis, Phase II, Transcription factor GATA-3, dermal application, Proof-of-Concept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sterna Biologicals GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Mar 2014 (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.
Atopic dermatitis (AD) is a chronic or chronic recurring inflammatory skin disorder. Patients suffer from eczema and often severe pruritus on the affected skin, as well as from frequent complications and secondary infections. Next to a genetically predetermined defect in epidermal barrier function and vegetative dysfunction, AD arises from an upregulation of Th2-modified immune responses inducing increased IgE-antibody production, cytokine secretion and subsequently, local inflammation.
Although standard therapies of AD, modern topical corticosteroids, show a better ratio of therapeutic effects to side effects, they retain a moderate acceptance due to their non-specific action, strict compliance requirements and possible adverse effects. As a newer alternative, calcineurin inhibitors show fewer side effects but raise concerns regarding long term risks including the possibility of skin carcinogenicity. Therefore, medical need remains for novel therapies for this major public health problem, directed in particular at specific early disease-causing mechanisms and/or molecular targets, with an improved efficacy, safety and compliance.
Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting early disease-causing mechanisms are a promising approach for the treatment of AD.
The transcription factor GATA-3 represents the key regulatory factor of Th2-driven immune responses. It is indispensable for the differentiation and activation of Th2 cells; it integrates Th2 signals and induces Th2 cytokine expression. The investigational product SB011 contains the DNAzyme hgd40 that targets GATA-3. By cleaving GATA-3 mRNA hgd40 reduces specific cytokine production and thereby reduces key features of allergic airway inflammation.
DNAzymes are completely generated by chemical synthesis and can be produced under Good Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by use of any living organism including cell culture or bacteria. The molecules are highly water-soluble and will be applied as a water/oil/water (W/O/W) formulation since multiple emulsions have been shown to protect the active ingredient from degradation on the skin and have penetration enhancing properties in comparison to other carrier systems.
This proof-of-concept study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the topical formulation SB011 containing 2 % hgd40 twice daily (BID) in patients with mild to moderate atopic eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB011, 2 % (Water/Oil/Water) emulsion of hgd40 | Experimental | Drug: SB011, 2 % (Water/Oil/Water) emulsion of hgd40All patients will perform treatment with formulation SB011 containing 2 % hgd40 and the active ingredient-free vehicle. The comparison of the IMPs will be performed intraindividually. Comparison and random assignment of treatments to two distinct treatment areas (area 1, area 2). IMP SB011: Topical application of approximately 5 mg/cm2 (250 μl) per treatment area (50 cm2) twice daily on 14 consecutive days, one single last application at the site on Day 15 (29 treatments) daily dosage: Approximately 10 mg hgd40 total dosage: Approximately 145 mg hgd40 |
| Multiple W/O/W formulation, active ingredient-free vehicle | Placebo comparator | Drug: Multiple W/O/W formulation, active ingredient-free vehicleAll patients will perform treatment with formulation SB011 containing 2 % hgd40 and the active ingredient-free vehicle. The comparison of the IMPs will be performed intraindividually. Comparison and random assignment of treatments to two distinct treatment areas (Area 1, Area 2). Vehicle: Topical application of approximately 5 mg/cm2 (250 μl) per treatment area (50 cm2) twice daily on 14 consecutive days, one single last application at the site on Day 15 (29 treatments) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient oral and written informed consent
- Adult Caucasian patients (male and female) aged 18-69 years (both included);
- Patients smoking ≤ 10 cigarettes/day
- Patient has confirmed diagnosis of atopic dermatitis using the diagnostic features as described by Hanifin and Rajka, initial diagnosis made at least 12 weeks before first treatment;
- SCORAD (12) between 20 and 50 (mild to moderate atopic dermatitis);
Key exclusion criteria (31 listed)
- History of allergic reactions to any active or inactive component of the IMP;
- Presence of clinically significant diseases other than asthma or atopic diseases (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.) which in the opinion of the investigator, influence the results of the trial or the patient's ability to take part in it;
- Inherent or acquired immune deficiency, immune deficiency in consequence of drug use;
- Immune mediated diseases;
- Suntan, hyperpigmentation or tattoos in the test fields;
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 |
|---|---|---|
| SB011, 2 % (Water/Oil/Water) emulsion of hgd40Also: Active drug substance is hgd40Treatment will be performed BID on 14 consecutive days and one single last application at the site on Day 15 (29 applications in total). Two preferably disseminated and contralateral, comparable lesional treatment areas of approximately 50 cm2 each and located on arms, legs, chest, stomach or neck will be chosen. All patients will perform treatment with both formulation SB011 containing 2% hgd40 and the active ingredient-free vehicle. Comparison of the IMPs will be performed intraindividually. Approximately 5 mg/cm2 (250 μl) of SB011 (2% hgd40) and the vehicle will be applied to the respective treatment areas. The time between the two applications should include min. 8 hours and max. 16 hours. Patients compliance will be controlled by weighing of the IMPs at each visit. On day 1 the application of the IMPs will be demonstrated to the patients at the clinical site. The first treatment as well as the morning treatment on Days 3, 5, 8, 12, and 15 will be carried out at the clinical site | Drug | SB011, 2 % (Water/Oil/Water) emulsion of hgd40 |
| Multiple W/O/W formulation, active ingredient-free vehicleTreatment will be performed BID on 14 consecutive days and one single last application at the site on Day 15 (29 applications in total). Two preferably disseminated and contralateral, comparable lesional treatment areas of approximately 50 cm2 each and located on arms, legs, chest, stomach or neck will be chosen. All patients will perform treatment with both formulation SB011 containing 2% hgd40 and the active ingredient-free vehicle. Comparison of the IMPs will be performed intraindividually. Approximately 5 mg/cm2 (250 μl) of SB011 (2% hgd40) and the vehicle will be applied to the respective treatment areas. The time between the two applications should include min. 8 hours and max. 16 hours. Patients compliance will be controlled by weighing of the IMPs at each visit. On day 1 the application of the IMPs will be demonstrated to the patients at the clinical site. The first treatment as well as the morning treatment on Days 3, 5, 8, 12, and 15 will be carried out at the clinical site | Drug | Multiple W/O/W formulation, active ingredient-free vehicle |
Primary outcome
Change of local SCORing atopic dermatitis (SCORAD) from baseline to Day 15.
Time frame: On baseline (day 1) and on day 15 (Last day after 2 Weeks IMP administration)
The following parameters are included in scoring: A: the extent of the involved body area; B: the intensity of the criteria erythema, edema/papulation, oozing/crusts, excoriations,lichenification and dryness, whereby dryness is evaluated on uninvolved areas; C: the subjective symptoms of pruritus at application areas and sleep loss evaluated on a visual analogue scale from 0 to 10 (average for the last three days or nights) and added. The intensity of each of the criteria erythema, edema/papulation, oozing/crusts, excoriations, lichenification and dryness will be graded according to the following 4 point scale: 0 = absent 1. = mild 2. = moderate 3. = severe Each single parameter for SCORAD calculation will be documented on a source document. The SCORAD will be calculated according to the formula A/5 + 7B/2 + C and documented in the source documents and the CRF.
11 secondary outcomes
The change from baseline in modified local SCORAD
Time frame: On Days 3, 5, 8, and 12
Modified local SCORAD
Time frame: on Days 1, 3, 5, 8, 12, and 15
Change from baseline in transepidermal water loss (TEWL)
Time frame: On Days 3, 5, 8, 12, and 15
TEWL on Days 1, 3, 5, 8, 12, and 15
Time frame: Days 1, 3, 5, 8, 12, and 15
Subjective assessment of pruritus using a 10-point rating scale
Time frame: Days 1, 3, 5, 8, 12, and 15
Subjective efficacy assessment on Days 3, 5, 8, 12 and 15
Time frame: Days 3, 5, 8, 12 and 15
Subjective dermal tolerability assessment using a 5-point rating scale on Days 3, 5, 8, 12 and 15
Time frame: Days 3, 5, 8, 12 and 15
Pharmacokinetic outcome measure
Time frame: Day 1 and Day 15
Physical examination of the skin and Vital signs
Time frame: Screening period and day 16
Adverse Events
Time frame: Including the whole screening period and the experimental phase day -14 to day 16
Standard Safety laboratory
Time frame: Screening period + on days 1, 5 and 16 in the Treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
Related trials for Mild to Moderate Atopic Dermatitis
RecruitingPhase 2
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis
Dermatitis Atopic
Not yet recruitingPhase 2
To Evaluate the Safety and Efficacy of Hemay5394 in Patients With Mild to Moderate Atopic Dermatitis
Safety, Efficiency
Not yet recruitingPhase 2
A Study of JYP0066 Cream in Mild-to-Moderate Atopic Dermatitis
Atopic Dermatitis (AD)
Recruiting
Double-blind, Randomized, Non-inferiority Trial in Atopic Dermatitis: Comparison of Lipikar Balm and Relipid+ Balm in the Treatment of Mild to Moderate Atopic Dermatitis in Children and Adults
Atopic Dermatitis, Emollients
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients
Mild to Moderate Atopic Dermatitis
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.
Thomas Werfel, Prof. Dr. principal investigator
Division for Immunodermatology and Allergy Research Clinic for Dermatology, Allergy and Venereology Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB011, 2 % (Water/Oil/Water) emulsion of hgd40 in people with Mild to Moderate Atopic Dermatitis, run by Sterna Biologicals GmbH & Co. KG at 1 site in Germany.
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 15 inclusion and 31 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: finished, as of the sponsor's last update on 13 Jan 2017. 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 Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of local SCORing atopic dermatitis (SCORAD) from baseline to Day 15. (time frame: On baseline (day 1) and on day 15 (Last day after 2 Weeks IMP administration)). 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 13 Jan 2017.