Patients with mild to moderate facial papulopustular acne (acne comedonica or acne papulopustulosa) will be enrolled in the study. MedDRA version: 16.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: DS107E DGLA Cream
Pharmaceutical Form: Cream
INN or Proposed INN: proposed DIGAMOLENIC ACID and DIGAMOLENATE
CAS Number: 1783-84-2
Current Sponsor code: DS107E-03
Other descriptive name
Sponsors
Dignity Sciences Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically confirmed diagnosis of facial acne papulopustulosa or acne papulopustulosa et comedonica with a mild to moderate intensity (grade 2 to 8 according to the revised Leeds Scale of Acne Grading) and with at least 12 inflammatory lesions excluding the nose 2. General good health as confirmed by a physical examination and by medical history 3. Acceptance to abstain from any other systemic or topical acne treatment during trial 4. Acceptance to abstain from prolonged UV exposure via intensive sunbathing, the use of tanning equipment or outdoor pursuits such as mountain sports activities 5. Male or female patients aged 16 to 40 years on the day of signing the informed consent form (ICF). 6. Patients who are able and willing to give signed informed consent (ICF). 7. Body mass index (BMI) of between 18 and 30 kg/m2 inclusive. 8. Patients taking oral contraceptives containing compounds with known effects on acne are allowed providing that the subject has been on stable dose for 6 months prior to enrollment. Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Females with a positive pregnancy test at baseline 2. Females of childbearing potential and female partners of male patients who have not used for 6 months prior to the trial and are not willing to use for the duration of the trial; a safe contraceptive measure (e.g. IUD or oral contraceptives, diaphragm or condom if used in combination with a spermicide) 3. Diagnosis of any acneiform diseases like exogenous acne, drug induced acne, cosmetic induced acne 4. Presence of more than 2 nodules on the face. Up to two nodules are allowed. 5. Localisation of acne that requires treatment predominantly on the chest and/or the back 6. Patients with any clinically significant abnormal laboratory results at screening (biochemistry, haematology, urinalysis). 7. Other skin conditions that might interfere with acne diagnosis and/or evaluation (such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and papulo-pustular rosacea) 8. Treatment with any of the following medications within a timeframe prior to screening assessment of: -Corticosteroids, antibiotics (except plain penicillins) 4 weeks -Other systemic acne treatments (including isotretinoin) 6 months -Spironolactone 3 months. 9. Patients taking oral contraceptives containing compounds with known effects on acne; these include norethisterone/norethindrone, drospirenone, ciproterone acetate and norgestimate and other oral contraceptives who are not on stable dose for 6 months prior to enrollment. 10. Patients taking hormonal contraception solely for the control of acne 11. Treatment with any other topical acne drug within the last 14 days prior to the screening assessment 12. Presence of a significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease 13. Recent history of alcohol or any other substance abuse 14. Treatment with any experimental drug within 30 days prior to the screening assessment 15. Inability to comply with the study protocol 16. Patients who have received phototherapy (UVA, UVB) within 4 weeks of screening (Visit 1). 17. Patients with clinically significant impairment of renal or hepatic function. 18. Patients with a history of hypersensitivity to any substance in the IMP. 19. Patients with severe acne vulgaris or nodulocystic acne 20. Patients with a history of clinically relevant ECG abnormalities. 21. Patients with a known medical history of chronic infectious disease (HCV, HBV, HIV). 22. Patients who are investigational site staff members or relatives of those site staff members or patients who are relatives of Dignity Sciences employees directly involved in the conduct of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Efficacy: - Change in Investigators Global Assessment (IGA) of acne severity from baseline to the end of week 12 - Change of total count of acne lesions from baseline to the end of week 12;Main Objective: Primary Objective: To compare the efficacy of different concentrations of the study treatment DGLA cream on facial papulopustular acne in comparison to a placebo control. ;Secondary Objective: Secondary Objectives: To assess the safety and tolerability of topically applied DS107E DGLA Cream in different concentrations. ;Primary end point(s): Efficacy: 1. Change in Investigators Global Assessment (IGA) of acne severity from baseline to the end of week 12 2. Change of total count of acne lesions from baseline to the end of week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: a) Change in Investigators Global Assessment (IGA) of acne severity after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment). b) Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (all acne lesions, count of comedones, papules and pustules and total count of inflammatory lesions) c) Time to reduction of acne lesions by > 30%;Timepoint(s) of evaluation of this end point: Efficacy: a) Change in Investigators Global Assessment (IGA) of acne severity after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment). b) Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (all acne lesions, count of comedones, papules and pustules and total count of inflammatory lesions) c) Time to reduction of acne lesions by > 30% | — |
Countries
Germany, Hungary
Contacts
Public ContactLaura Hopkins
Dignity Sciences Limited
Outcome results
None listed