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The goal of this study is to learn if isotretinoin oral tablets as a weekend regimen are safe and effective to maintain freedom from acne lesions in young adults who have completed a full course of isotretinoin on daily basis and achieved total control of the acne activity.
Three groups of adult acne patients will be given a full course of isotretinoin with a cumulative dose of 120-150 mg/Kg weight in the 1st two groups, and till lesional clearance in the 3rd group with an additional month of maintenance. Afterwards, the 1st group will use adapalene gel every other day for maintenance, the 2nd and 3rd groups will use weekend oral isotretinoin. Patients will be followed for a year for reappearance of acne lesions, and safety of maintenance regimens. Patients opinion will be also sought.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene group | Active Comparator | Patients received full Isotretinoin course for treatment, and maintained on every other day adapalene gel. |
|
| Full Iso group | Active Comparator | Patients received full isotretinoin course for treatment, and maintained on weekend isotretinoin. |
|
| Clearance Iso | Active Comparator | Patients treated by systemic isotretinoin till full clearance and for a month thereafter, and maintained on weekend isotretinoin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotretinoin capsules | Drug | A one year follow up for patients on three maintenance regimens after acne clearance, including weekend isotretinoin and adapalene gel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acne relapse during maintenance phase | percent of patients having one grade worsening of their acne investigator global assessment scale achieved by end of treatment phase as assessed by the physician during follow up | one year |
| Timing of acne relapse after initiating maintenance | The time interval between initiating maintenance and the occurrence of one grade worsening of the patient's investigator global assessment scale achieved by the end of treatment phase as assessed by the physician during follow up | one year |
| Maximum severity of acne relapse during follow up | Maximum investigator global assessment score reached by the the patient during the follow up year | One year |
| Incidence of adverse effects | Percent of patients reporting adverse effects in general, percent of patients reporting each category of side effects, including disturbed lipid profile, raised transaminases, psychological changes, dryness, hair shedding, ... | One year |
| Measure | Description | Time Frame |
|---|---|---|
| subjective patient satisfaction by maintenance regimen | A patient oriented outcome, in which the patients are asked by the end of maintenance year to report their degree of satisfaction by the efficacy of maintenance regimen to prevent acne relapse on a visual analogue scale of 1-10, in which 1 is lowest satisfaction and 10 is highest satisfaction. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Farid, MD | Professor of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Alexandria | 2500 | Egypt |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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Interventional study on 3 parallel groups, with random assignment and longitudinal follow up, conducted in two phases (treatment and maintenance).
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The assessor responsible for the follow up (assessing primary and secondary measures) during the treatment and maintenance phases was blinded to the line of treatment used.
|
| Subjective convenience of maintenance regimen to patient | A patient oriented outcome to assess the degree of convenience of the maintenance regimen for the patient as reported on a visual analogue scale of 1-10, where 1 is the lowest convenience, and 10 is the highest convenience. | one year |
| Hydrocarbons, Acyclic |
| 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 |