Topical treatments
Tretinoin (topical)
Nesta seção:
Key points | Benefits and harms | Comment
Key points
- For GRADE evaluation of interventions for Acne vulgaris, see table.
- Topical preparations of tretinoin may reduce inflammatory and non-inflammatory lesions, but can also cause redness, burning, dryness, and soreness of the skin.
- Topical tretinoin has been associated with erythema, peeling, burning, and pruritus.
- Topical retinoids are not recommended in women of childbearing age not taking adequate contraceptive precautions, or during pregnancy.
Benefits and harms
Topical tretinoin versus placebo:
We found one systematic review[16] (search date 1999, 5 RCTs,[40][41][42][43][44] 802 people with mild to moderate acne, 257 people with moderate to severe acne) comparing topical tretinoin 0.02%, 0.025%, or 0.05% versus vehicle twice daily for 8 to 12 weeks. The review did not perform a meta-analysis because of heterogeneity among the RCTs in methods of outcome assessment.[16]
Acne severity
Topical tretinoin compared with placebo Topical tretinoin may be more effective at 8 to 12 weeks at reducing the number of inflammatory and non-inflammatory lesions in people with mild to severe acne (low-quality evidence).
| Ref (type) | Population | Outcome, Interventions | Results and statistical analysis | Effect size | Favours |
|---|---|---|---|---|---|
Total lesion count |
|||||
|
RCT 3-armed trial |
215 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Percentage reduction in total lesion count, 12 weeks 40% with tretinoin 0.025% 24% with vehicle Other comment Absolute results estimated from graph |
P <0.05 |
not-calculated |
Tretinoin |
|
RCT 3-armed trial |
271 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Percentage reduction in total lesion count, 12 weeks 39% with tretinoin 0.025% 28% with vehicle Other comment Absolute results estimated from graph |
P <0.05 |
not-calculated |
Tretinoin |
Non-inflammatory lesions |
|||||
|
RCT 3-armed trial |
256 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.02% |
Comedones (measured by total score), 7 to 8 weeks 89 with tretinoin 0.05% 131 with vehicle Other comment Completer analysis, no intention-to-treat analysis |
P <0.01 for tretinoin 0.05% v vehicle The RCT had weak methods for assessing outcomes |
not-calculated |
Tretinoin |
|
RCT 3-armed trial |
256 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.05% |
Comedones (measured by total score), 7 to 8 weeks 94 with tretinoin 0.02% 131 with vehicle Other comment Completer analysis, no intention-to-treat analysis |
P <0.01 for tretinoin 0.02% v vehicle The RCT had weak methods for assessing outcomes |
not-calculated |
Tretinoin |
|
RCT 3-armed trial |
257 people with moderate to severe acne In review [16] Other comment The remaining arm evaluated motretinide 0.1% |
Number of non-inflammatory lesions, 8 weeks 89 with tretinoin 0.05% twice daily 131 with vehicle twice daily |
P = 0.01 |
not-calculated |
Tretinoin |
|
RCT 3-armed trial |
215 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Percentage reduction in non-inflammatory lesions, 12 weeks 39% with tretinoin 0.025% 19% with vehicle Other comment Absolute results estimated from graph |
P <0.05 |
not-calculated |
Tretinoin |
|
RCT 3-armed trial |
271 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Percentage reduction in non-inflammatory lesions, 12 weeks 49% with tretinoin 0.025% 31% with vehicle Other comment Absolute results estimated from graph |
P <0.05 |
not-calculated |
Tretinoin |
Inflammatory lesions |
|||||
|
RCT 3-armed trial |
256 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.02% |
Number of papules (measured by total score), 7 to 8 weeks 61 with tretinoin 0.05% 83 with vehicle Other comment Completer analysis, no intention-to-treat analysis |
P <0.05 for tretinoin 0.05% v vehicle The RCT had weak methods for assessing outcomes |
not-calculated |
Tretinoin 0.05% |
|
RCT 3-armed trial |
256 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.05% |
Number of papules (measured by total score), 7 to 8 weeks 76 with tretinoin 0.02% 83 with vehicle Other comment Completer analysis, no intention-to-treat analysis |
Reported as not significant for tretinoin 0.02% v vehicle P value not reported The RCT had weak methods for assessing outcomes |
not-significant |
not significant |
|
RCT 3-armed trial |
257 people with moderate to severe acne In review [16] Other comment The remaining arm evaluated motretinide 0.1% |
Number of papules, 8 weeks 61 with tretinoin 0.05% twice daily 83 with vehicle twice daily |
P = 0.05 |
not-calculated |
Tretinoin |
|
RCT 3-armed trial |
215 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Percentage reduction in papules, 12 weeks 42% with tretinoin 0.025% 19% with vehicle Other comment Absolute results estimated from graph |
P <0.05 |
not-calculated |
Tretinoin |
|
RCT 3-armed trial |
271 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Percentage reduction in papules, 12 weeks 49% with tretinoin 0.025% 28% with vehicle Other comment Absolute results estimated from graph |
P <0.05 |
not-calculated |
Tretinoin |
No data from the following reference on this outcome.[42]
Patient perception of improvement
Topical tretinoin compared with placebo We don't know whether topical tretinoin is more effective at increasing patient perception of improvement in people with mild to moderate acne (very low-quality evidence).
| Ref (type) | Population | Outcome, Interventions | Results and statistical analysis | Effect size | Favours |
|---|---|---|---|---|---|
Patient perception of improvement |
|||||
|
RCT 3-armed trial |
60 people with mild to moderate acne In review [16] |
Patient perception of severity on a visual analogue scale (VAS), 12 weeks 18 with tretinoin 0.05% or 0.025% 39 with vehicle Other comment Range of VAS not specified |
Significance not assessed The RCT had weak methods for assessing outcomes | ||
Psychological distress
No data from the following reference on this outcome.[40][41][42][43][44]
Quality of life
No data from the following reference on this outcome.[40][41][42][43][44]
Adverse effects
| Ref (type) | Population | Outcome, Interventions | Results and statistical analysis | Effect size | Favours |
|---|---|---|---|---|---|
Erythema |
|||||
|
RCT 3-armed trial |
256 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.02% |
Erythema, peeling, or both, 1 to 3 weeks 86% with tretinoin 0.05% 40% with vehicle Other comment Completer analysis, no intention-to-treat analysis |
P <0.01 for tretinoin 0.05% v vehicle |
not-calculated |
Vehicle |
|
RCT 3-armed trial |
256 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.05% |
Erythema, peeling, or both, 1 to 3 weeks 81% with tretinoin 0.02% 40% with vehicle Other comment Completer analysis, no intention-to-treat analysis |
P <0.01 for tretinoin 0.02% v vehicle |
not-calculated |
Vehicle |
|
RCT 3-armed trial |
257 people with moderate to severe acne In review [16] Other comment The remaining arm evaluated motretinide 0.1% |
Erythema and desquamation, 8 weeks 76/84 (90%) with tretinoin 0.05% twice daily 16/84 (19%) with vehicle twice daily |
P <0.005 |
not-calculated |
Vehicle |
|
RCT 3-armed trial |
215 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Proportion of people with erythema, 12 weeks 20% with tretinoin 0.025% 9% with vehicle Other comment Absolute results estimated from graph |
P <0.005 |
not-calculated |
Vehicle |
|
RCT 3-armed trial |
271 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Proportion of people with erythema, 12 weeks 8% with tretinoin 0.025% 3% with vehicle Other comment Absolute results estimated from graph |
P <0.005 |
not-calculated |
Vehicle |
Burning |
|||||
|
RCT 3-armed trial |
257 people with moderate to severe acne In review [16] Other comment The remaining arm evaluated motretinide 0.1% |
Burning, 8 weeks 69/84 (82%) with tretinoin 0.05% twice daily 23/84 (27%) with vehicle twice daily |
P <0.005 |
not-calculated |
Vehicle |
|
RCT 3-armed trial |
271 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Proportion of people with burning, 12 weeks 8% with tretinoin 0.025% 3% with vehicle Other comment Absolute results estimated from graph |
P <0.005 |
not-calculated |
Vehicle |
Itching |
|||||
|
RCT 3-armed trial |
257 people with moderate to severe acne In review [16] Other comment The remaining arm evaluated motretinide 0.1% |
Pruritus, 8 weeks 62/84 (74%) with tretinoin 0.05% twice daily 26/84 (31%) with vehicle twice daily |
P <0.005 |
not-calculated |
Vehicle |
|
RCT 3-armed trial |
271 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Proportion of people with itching, 12 weeks 15% with tretinoin 0.025% 6% with vehicle Other comment Absolute results estimated from graph |
P <0.005 |
not-calculated |
Vehicle |
Peeling |
|||||
|
RCT 3-armed trial |
215 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Proportion of people with peeling, 12 weeks 21% with tretinoin 0.025% 3% with vehicle Other comment Absolute results estimated from graph |
P <0.005 |
not-calculated |
Vehicle |
Dryness |
|||||
|
RCT 3-armed trial |
215 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Proportion of people with dryness, 12 weeks 21% with tretinoin 0.025% 8% with vehicle Other comment Absolute results estimated from graph |
P <0.005 |
not-calculated |
Vehicle |
Skin tightness |
|||||
|
RCT 3-armed trial |
271 people with mild to moderate acne In review [16] Other comment The remaining arm evaluated tretinoin 0.025% plus polyolprepolymer-2 |
Proportion of people with skin tightness, 12 weeks 22% with tretinoin 0.025% 15% with vehicle Other comment Absolute results estimated from graph |
P <0.005 |
not-calculated |
Vehicle |
Further information on studies
None.
Comment
Birth defects:
We found no RCTs assessing the risk of birth defects in women using topical retinoids. One non-systematic review found that oral retinoids were teratogenic in case reports and case series in humans, and in experimental studies in animals.[45] In the absence of data regarding the risk of birth defects, it is recommended that topical retinoids are not used during pregnancy, or by women of childbearing age not taking adequate contraceptive precautions.[7]
Clinical guide:
Topical retinoids or topical antibiotics are indicated as treatment for mild acne that does not respond to benzoyl peroxide. Within the retinoid class, there is more evidence of benefit with topical tretinoin than with isotretinoin or adapalene. It is recommended that topical retinoids are not used during pregnancy, or by women of childbearing age not taking adequate contraceptive precautions.[7]
Data de publicação na web: 5 Jan 2011 (based on February 2010 search)
