Clinical trials: Isotretinoin
Neuroblastoma
Oral Liquid 13-cis-retinoic Acid (13-CRA)
An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - < 21 years.
- Trial name
- My-CRA (NCT03291080)
- Testing
- Liquid 13-Cis Retinoic Acid, Extracted capsules 13-CRA
- Where
- 10 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Nova Laboratories Limited
Healthy
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin) Capsules 40 mg after single oral dose…
- Trial name
- NCT01888224
- Testing
- Isotretinoin
- Where
- India
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Neuroblastoma
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or the National Cancer Institute [NCI]).
- Trial name
- NCT01592045
- Testing
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- United Therapeutics
Acne
Combination Treatment for Moderate to Severe Acne
To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne
- Trial name
- NCT01206348
- Testing
- Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
- Where
- 10 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Medicis Global Service Corporation
Acne Vulgaris
A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition
This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin.
- Trial name
- NCT02498288
- Testing
- Isotretinoin: Reference Medication 1, Isotretinoin: Reference Medication 2, Isotretinoin: Test Medication
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neuroblastoma
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
This is a single-arm, uncontrolled, international, multi-center, clinical,phase 2 trial, in patients ≥ 12 months of age with high-risk neuroblastoma in first remission.
- Trial name
- NCT04909515
- Testing
- Naxitamab, GM-CSF, Isotretinoin
- Where
- 9 sites in Hong Kong, Russia and 2 more
- Sponsor
- Y-mAbs Therapeutics
Primary Refractory Neuroblastoma
A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients
This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF.
- Trial name
- NCT00969722
- Testing
- MAb-3F8, Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), 13-cis-Retinoic Acid
- Where
- 15 sites in United States
- Volunteers
- 1 people
- Sponsor
- United Therapeutics
Healthy
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions
- Trial name
- NCT01888289
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Severe Nodular Acne
Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne
The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily with meals.
- Trial name
- NCT00975143
- Testing
- CIP-Isotretinoin, Isotretinoin
- Where
- 49 sites in United States, Canada
- Volunteers
- 925 people
- Sponsor
- Cipher Pharmaceuticals Inc.
Papular-pustular Rosacea
Isotretinoin in Papular-Pustular Rosacea
A national, multicentre, prospective, randomised, double-blind, phase III study in 2 parallel groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea resistant to standard therapy.
- Trial name
- ISOROS (NCT00882531)
- Testing
- isotretinoin
- Volunteers
- 156 people
- Sponsor
- Laboratoires Bailleul-Biorga
Healthy
Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions
- Trial name
- NCT01888341
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Acne
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
- Trial name
- NCT02457520
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Skin Infections (Acne)
Bioequivalence Study for an Isotretinoin
The objective of this study was to confirm if two formulations of isotretionin (capsules) are bioequivalent. Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product Roaccutan® 20 mg (Productos…
- Trial name
- NCT01863615
- Testing
- Isotretinoin 40 mg
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neuroblastoma
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.
This is a single-arm, multicenter clinical trial conducted in patients ≥ 12 months of age with high-risk neuroblastoma in first complete response.
- Trial name
- NCT06047535
- Testing
- Naxitamab
- Volunteers
- 62 people
- Sponsor
- SciClone Pharmaceuticals
Acne
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.
- Trial name
- POWER (NCT01474590)
- Testing
- Epiduo/Tactuo, vehicle gel, doxycycline 200mg
- Where
- 25 sites in Canada
- Volunteers
- 266 people
- Sponsor
- Galderma R&D
Acne
Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subjects With Facial Acne.
The aim of this study is to evaluate the efficacy of the RV3278B-OS0386 cosmetic product, compared to the control product in managing acne relapse during the 12-month maintenance phase follow-up after oral isotretinoin treatment…
- Trial name
- NCT07341659
- Testing
- Test product RV3278BB-OS0386, Control product RV3278B-OS0548
- Where
- 5 sites in France, Italy and 1 more
- Volunteers
- 102 people
- Sponsor
- Pierre Fabre Dermo Cosmetique
Healthy
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fed conditions
- Trial name
- NCT01888328
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited