Retin-A Micro (Tretinoin Topical) - Summary

RETIN-A MICRO SUMMARY

RETIN-A MICRO® (tretinoin gel) microsphere, 0.1% and 0.04%

Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. Other components of this formulation are purified water, carbomer 974P (0.04% formulation), carbomer 934P (0.1% formulation), glycerin, disodium EDTA, propylene glycol, sorbic acid, PPG-20 methyl glucose ether distearate, cyclomethicone and dimethicone copolyol, benzyl alcohol, trolamine, and butylated hydroxytoluene.

Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established.

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NEWS HIGHLIGHTS

Media Articles Related to Retin-A Micro (Tretinoin Topical)

Health Tip: What's Triggering My Acne?
Source: MedicineNet Acne Specialty [2009.06.24]
Title: Health Tip: What's Triggering My Acne?
Category: Health News
Created: 6/24/2009 7:00:00 AM
Last Editorial Review: 6/24/2009

New Laser Combo Therapy Zaps Acne
Source: MedicineNet Acne Specialty [2009.03.09]
Title: New Laser Combo Therapy Zaps Acne
Category: Health News
Created: 3/7/2009 2:00:00 AM
Last Editorial Review: 3/9/2009

Acne Cream Not Linked to Raised Death Risk
Source: MedicineNet tretinoin Specialty [2009.01.26]
Title: Acne Cream Not Linked to Raised Death Risk
Category: Health News
Created: 1/24/2009 2:00:00 AM
Last Editorial Review: 1/26/2009

FDA OKs New Acne Gel Epiduo
Source: MedicineNet adapalene Specialty [2009.01.07]
Title: FDA OKs New Acne Gel Epiduo
Category: Health News
Created: 1/7/2009
Last Editorial Review: 1/7/2009

Acne (Pimples)
Source: MedicineNet Boils Specialty [2008.07.16]
Title: Acne (Pimples)
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 7/16/2008

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Published Studies Related to Retin-A Micro (Tretinoin Topical)

Tolerability of high-dose topical tretinoin: the Veterans Affairs Topical Tretinoin Chemoprevention Trial. [2009.10]
BACKGROUND: Topical tretinoin is a medication commonly used for acne that has potential application in the long-term treatment of photodamaged skin. However, there are few published data regarding the tolerability of high-dose tretinoin with long-term use. OBJECTIVES: To assess the long-term tolerability of tretinoin 0.1% cream... CONCLUSIONS: Overall, the tolerability level of topical tretinoin was high in this study population, with almost 40% of the tretinoin group reporting no side-effects, and the majority (67%) tolerating at least once-daily dosing at 6-month follow-up. High-dose topical tretinoin is feasible for long-term use in this population.

Quality of life in the actinic neoplasia syndrome: The VA Topical Tretinoin Chemoprevention (VATTC) Trial. [2009.08]
BACKGROUND: Keratinocyte carcinomas (KCs) are the most common malignancies of the skin. As lesions have a low mortality rate, understanding quality-of-life (QoL) factors is necessary in their management. OBJECTIVE: To assess QoL and associated patient characteristics in those with a history of keratinocyte carcinomas... CONCLUSIONS: A history of ever use of 5-FU and present AKs was strongly associated with worse QoL. We find it more useful to consider these patients as having the chronic condition "actinic neoplasia syndrome," whose burden may be best measured by factors other than their history of KCs.

Reappraising the phototoxicity of tretinoin: a report of four controlled clinical trials. [2009.06]
BACKGROUND: Retinoids are photoreactive molecules found in skin and retinal tissue. The use of retinoids in pharmacologic doses, applied topically, raises the potential of phototoxicities. Recent review articles and current US drug labeling indicate that tretinoin is a phototoxin. In developing a new formulation of topical all-trans-retinoic acid (tretinoin), formal testing of dermal photoreactions was therefore undertaken... CONCLUSION: The findings in these studies are consistent with previous studies of tretinoin in various formulations, and support the conclusion that tretinoin appears to be neither phototoxic nor photoallergenic in vivo.

Tolerability of clindamycin/tretinoin gel vs. tretinoin microsphere gel and adapalene gel. [2009.04]
CONCLUSION: CLIN/RA was significantly better tolerated than was 0.1% tretinoin gel, as evidenced by significantly reduced erythema (P < 0.04), scaling (P < 0.03), itching (P < 0.02), burning (P < 0.03) and stinging (P < 0.04). A trend for greater erythema, scaling, and subjective discomfort for 0.1% adapalene gel compared to CLIN/RA was also evident.

Association between statin use and risk for keratinocyte carcinoma in the veterans affairs topical tretinoin chemoprevention trial. [2009.01.06]
BACKGROUND: Recent evidence suggests that statins may prevent cancer. OBJECTIVE: To quantify the association between statin use and the occurrence of keratinocyte carcinoma in high-risk veterans... CONCLUSION: These data show no conclusive or consistent relationship between long-term statin use and risk for keratinocyte carcinoma.

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Clinical Trials Related to Retin-A Micro (Tretinoin Topical)

Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment [Terminated]
The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery.

Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris [Completed]

Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U. S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.

The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a “pretend” injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).

This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a “pretend” injection.

Clinical Evaluation of the Photoallergy Potential of Atralin Gel [Completed]
To assess the potential of tretinoin gel 0. 05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.

Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris [Recruiting]
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0. 025% compared with tretinoin gel 0. 025% monotherapy in treating moderate to severe facial acne vulgaris

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PATIENT REVIEWS / RATINGS / COMMENTS

Retin-A Micro review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		blackheads,large pores,sun damage
Dosage & duration:		0.1% (dosage frequency: every other night) for the period of 1 year
Other conditions:		fine lines
Other drugs taken:		claritin
		Reported Results
Benefits:		I saw measurable difference in reduction of blackheads and pore size. I was also really happy with the evening of pigmentation. I had sun and age spots as well as freckling and saw a huge difference in the lightening of all these problems. My skin had a much better over all tone a seemed to become firmer over time.
Side effects:		The first few weeks of treatment my skin was peeling a little and I had some red splotches but eventually these symptoms went away.
Comments:		I would wash my face in the evening with a mild cleanser and then every other night when my face was completely dry I would apply a small amount of Retin-A to my face with the exception of the immediate eye area. The evenings that I did not use Retin-A I would use a good night moisturizer.

Retin-A Micro review by 61 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		photoaging
Dosage & duration:		pea sized amount at h.s. topically (dosage frequency: nightly) for the period of 2 months now
Other conditions:		large pores
Other drugs taken:		hctz
		Reported Results
Benefits:		I noticed significant smoothing and softening of lines on face, lightening of uneven coloring, reduction of frequency of blemishes, reduction in oiliness of skin and some tightening of the tissues of the facial skin. I would hope that the effects are long-lasting, but I have only used it for 2 months now.
Side effects:		I noticed dryness, photosensitivity, irritation of mucus membranes. I had to use moisturizer more than usual and reapply it during the day due to dryness. I used a broad spectrum UVA/UVB sunblock with it (Avene SPF 50
Comments:		I applied nightly to dry clean skin. I did not apply any moisturizer afterwards in order to avoid diluting the product. I used a mild cleanser for dry skin and exfoliated with a microfiber cloth once a week. I did not have any peeling. Some irritation in places.

Retin-A Micro review by 25 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Acne
Dosage & duration:		0.1% (dosage frequency: every night before bedtime) for the period of 3 months
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		None at all; my acne went from mild to severe. I woke up everyday with big new, painful whiteheads. Each time a group of pimples went away, several new ones formed immediately. I also have oily skin, and I read that Retin-A rapidly reduces oil; my skin is just as oily as the day I started and my acne is as bad as when I was a teenager.
Side effects:		My skin has been extremely red the entire time I've taken this medication. It is so drying that even my ears and lips are persistently dry. I need to wear chap stick all day, everyday just to keep my lips from peeling. The area where I most use the cream has also been extremely dry and flaky.
Comments:		I applied it every night before bedtime.