Sensizitation
To employ Samcyprone™ to treat cutaneous lesions the patient must first be sensitized to diphenylcyclopropenone (DPCP). Once successfully sensitized this step is not required for any future applications.
Aproxiamately 0.2 ml of 0.4% Samcyprone™ should be applied to an approximately 2.5 sq. cm (1 inch) of skin on the inner aspect of the upper arm. The area should be covered by a bandage such as Tegaderm to prevent the gel from spreading from the target area. (An alternative method is to apply the 0.4% Samcyprone™ gel directly to the bandage before applying both to the target area).
The patient should remove the bandage after approximately 24 hrs. The sensitized area should be washed and the bandage carefully disposed of in a sealed trash receptacle. The patient should be instructed that there will be little or no reaction at the sensitization site for 7 to 14 days. Some time between 7 to 14 days a “poision ivy” like rash that should neatly resemble the bandage area will appear. This rash will peak in 48 to 72 hrs and then completely resolve itself in 14 to 28 days. The patient should return to have the sensitization site skin reaction scored according to the method based on Alexander Fisher’s published allergic reaction Table:
0 – No skin reaction
1+ Erythema only
2+ Erythema and Cutaneous induration
3+ Erythema, papules and small vesicles.
4+ Large vesicles, bullae and severe local reaction besides erythema
A patient is considered sensitized to DPCP if they achieve a score of 2+ or greater. The sensitization process should be repeated if the patient’s score is less than 2.
Treatment Doses
Treatment
0.04% Samcyprone™ gel is used for treating the target lesion(s). It is important to start conservatively to determine how reactive the patient and the target skin is to Samcyprone™. The type of lesion and its location are critical in deciding how aggressively to apply Samcyprone™. A plantar or acral wart might require pretreatment and 24hr occlusion while a genital wart or an Alopecia Areata application may require only 15 minutes.
The treated lesion should develop an inflammatory reaction that will peak after 72 hrs. The goal is to establish a 2+ (Erythema and Cutaneous induration) reaction. Should the inflammatory reaction be greater than 3+ the treatment time for the next application should be reduced by half. If the reaction is less than 2+ the application time should be increased by half. This dose titration should be continually adjusted until a satisfactory inflammatory reaction occurs.
Gulati Et al. has established that Samcyprone’s™ Th1 reaction peaks at 72 hours and then quickly evolves into a Th2 reaction that returns to baseline levels by day 14. This cycle helps inform the physician on the frequency of the Samcyprone™ treatment doses. If you are treating a cutaneous melanoma or Squamous cell carcinoma legion it is recommended to apply the treatment dose every 4 or 5 days. Most published studies employing DPCP to treat warts use a treatment frequency of once a week. When treating Alopecia Areata the recommended treatment frequency is once every two weeks.
Lesion Type | Initial Dose Time | Dose Frequency |
Plantar, Acral, Keratinized Warts | 8 to 24 hours | Every 4 to 7 days |
General Body Warts | 4 to 8 hours | Every 4 to 7 days |
Head and Neck Warts | 1 to 2 hours | Every 4 to 7 days |
Genital Warts | 30 to 60 minutes | Every 7 days |
Melanoma – Squamous Cell Carcinoma | 2 to 4 hours | Every 4 to 7 days |
Alopecia Areata | 15 to 30 minutes | Every 14 to 21 days |
If the initial dose time results in an aggressive reaction of 3+ or greater the next treatment dose time should be reduced by half.
If the initial dose time results in a poor reaction of 1+ or less the next treatment dose time should be doubled.
The treatment dose time is then adjusted until the desired reaction level is achieved.
Pretreatment
Treatment of Plantar. Acral, and thickly keratinized warts will be more successful if the target warts are soaked in warm/hot water and where practical pared down with an emery board or other abrasive material. The softening and/or removal of the outer heavily keratinized skin of the wart before the application of the treatment dose will greatly improve the penetration of Samcyprone.
