Comparison of the efficacy, safety and tolerability of topically applied tretinoin formulated with TPM, a lead commercially available tretinoin cream and a vehicle (placebo) in the treatment of mild to moderate acne vulgaris
A Phase II, randomized, active and vehicle controlled, Investigator blind, multi-centre study to evaluate the efficacy, safety and tolerability of topically applied tretinoin formulated with TPM as an anti-acne preparation in human subjects with acne vulgaris.
Phosphagenics
45 participants
Jul 26, 2013
Interventional
Conditions
Summary
A multi centre, investigator blind, study in a total of 45 subjects with mild to moderate acne vulgaris aiming to evaluate the efficacy, safety and tolerability of topical tretinoin formulated with TPM compared with a commercially available tretinoin formulation, and a vehicle.
Eligibility
Inclusion Criteria4
- Minimum of 15 and Maximum of 60 inflammatory lesions on the face (papules and/ or pustules) and no more than one small nodulocystic lesion;
- Existence of a minimum of 50 non-inflammatory lesions on the face (blackheads/whiteheads);
- A score of 2 or 3 on the Investigator's Global Assessment (IGA) scale;
- Willing to minimise exposure to the sun, and avoid tanning booths and solariums
Exclusion Criteria7
- Severe acne vulgaris
- Facial skin condition other than acne vulgaris
- Facial hair, excessive scarring, sunburn or other disfigurement that may obscure assessment of acne counts or severity
- History of retinoid intolerance
- Subjects that are on topical/systemic acne treatment that does not meet the washout period
- Nursing/pregnant women
- The women were planning for pregnancy
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Interventions
Subjects will receive tretinoin (0.05%) formulated with tocopheryl phosphate mixture (TPM), a commercially available tretinoin formulation (0.05%), or a vehicle (placebo), which will be applied once daily for 3 months. TPM is a delivery system derived from Vitamin E that is able to increase the dermal absorption of tretinoin without increasing irritation. Each subject will be given written instructions entitled “Instructions for facial cleansing and study treatment application” that will outline the facial cleansing and study treatment application instructions. The instructions are briefly summarised below: 1. Gently wash entire face with the supplied skin cleanser, rinse immediately, pat the face dry with a towel 2. Leave the skin for 20 - 30 minutes before applying study treatment. 3. 30 - 60 minutes before bed, squeeze about a centimetre of the assigned study treatment onto your fingertip (while that should be enough for your whole face, after you have some experience with the medication you may find you need slightly more or less to do the job). 4. Dabbing it on your forehead, chin and both cheeks, then spreading it over the entire face. Smooth gently into the skin. The medication should become invisible almost immediately. If it is still visible, or if dry flaking occurs from the gel within a minute or so, you are using too much. 5. Keep the medication away from the corners of the nose, mouth, eyes and open wounds. 6. Wash hands thoroughly after application of the study treatment. 7. Ensure product is absorbed prior to sleeping. 8. Leave treated areas undisturbed overnight. Compliance will be monitored by use of a daily patient diary.
Locations(1)
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ACTRN12613000756729