Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. The primary endpoint will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
The investigators will recruit 162 participants with facial recalcitrant flat warts and randomize to the following three arms of intervention: Arm 1: nne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks; Arm 2: one capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks; and Arm 3: one capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. The primary endpoints will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial; and the incidence of side effects related to oral isotretinoin treatment among the 3 arms of treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotretinoin 10 mg/day | Experimental | One capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks. |
|
| Isotretinoin 20 mg/day | Experimental | One capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks. |
|
| Isotretinoin 30 mg/day | Active Comparator | One capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotretinoin capsules | Drug | Jelly capsules of isotretinoin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete clearance | Proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial. | 12 weeks |
| Incidence of serious adverse events | Proportion of participants that developed a serious side effect in the three arms during the clinical trial. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life index | Difference in the Dermatology Life Quality Index score at the end of the study, comparing with the basal score. The minimum score is 0 points and the maximum 30 points. A score higher than 10 points means that the patient's life is severely affected by melasma. | 12 weeks |
| Adherence to intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Have the following conditions:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MarÃa Guadalupe OlguÃn-GarcÃa, M.D., MSc. | Contact | 55387033 | 312 | olguingog@gmail.com |
| Martha Alejandra Morales-Sánchez, M.D., MSc. | Contact | 55387033 | 312 | mmoraless@sersalud.cdmx.gob.mx |
| Name | Affiliation | Role |
|---|---|---|
| MarÃa Guadalupe OlguÃn-GarcÃa, M.D.,MSc. | Centro Dermatológico Dr. Ladislao de la Pascua | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Dermatológico "Dr. Ladislao de la Pascua" | Mexico City | 06780 | Mexico |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| D012176 | Retinoids |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
Not provided
Not provided
Randomized clinical trial of three-arms
Not provided
Not provided
All the interventions will be similar in appearance and all the participants will take the same quantity of capsules.
Percentage of taken-doses of oral isotretinoin during the 12 weeks of the study. |
| 12 weeks |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |