A clinical trial was undertaken to study the effect of Issar Pharma’s decapeptide on normally pigmented and vitiligo-affected skin

The effect of the Decapeptide¹ was tested on both normal and vitiligo-affected skin samples in recent clinical trials.

The study was conducted by Issar Pharma at All India Medical Sciences, New Delhi; Himalayan Institute of Medical Sciences, Dehra Dun;  Vivekananda Hospital, Hyderabad; St. Johns Medical College, Bangalore and Owaisi Hospital and Research Center, Hyderabad, India, including 20 normally pigmented skin samples and 550 vitiligo skin patches.  Individuals in both groups received daily applications of the decapeptide at concentrations of 20 micro liters per 2x2 cm square area throughout the course of the study of 12 months.

Effect on Normal Skin:
The decapeptide was found to pigment all normal skin all 20, including dark skin, in a reversible and concentration-dependent manner.  The skin returned to its original color in three months once the peptide application was stopped.

Effect on Vitiligo Skin:
The decapeptide showed an overall 80% re-pigmentation rate in the vitiligo-affected treatment group.  No side effects were reported, and the treatment was well tolerated.

Treatment of Different Types of Vitiligo:
(a) Stable Vitiligo:
The most common method of treatment of stable, extensive vitiligo is currently the use of psoralens and UV-A/UV-B therapy.  These methods are only partially effective despite long durations of treatment and can produce negative side effects, including an increased risk of cancer for some populations. 

Clinical trails were undertaken in human volunteers to test the efficacy and safety of bFGF derived peptide- Melgain^® to repigment vitiligo patches of vitiligo volunteers.

The results of the above clinical trials demonstrated that irrespective of the type of vitiligo, the bFGF derived peptide- Melgain^® was effective to repigment in about 80% of cases including segmental type, which was most resistant to treatment.  The representative data for treatment of stable vitiligo are shown in the Case Studies Section.

Forehead: Before treatment

Forehead: After Combined Treatment with Melgain® and Psoralens

Please note here that the second photograph (above) was taken during the process of treatment.

(b) Fast Spreading Vitiligo:
The primary therapy presently used to treat fast-spreading vitiligo is the oral/local application of steroids, though this method often produces undesirable side effects. The combined therapy of bFGF-derived peptide and a drastically reduced dose of steroid was used to repigment fast-spreading vitiligo patches with more than 80% success in both arresting the disease and in repigmenting the vitiligo patches.   Demonstrative data are shown below.

Face: Before the treatment.	Face: After the treatment.

Combination with Other Treatment: Please consult your dermatologist before pursuing combination treatments.

Note : ¹Dr. A Ramaiah is the inventor and the Indian patent is jointly owned by Issar and Dr. A Ramaiah and exclusive right to manufacture and sell the product in India is given by Dr. A Ramaiah to Issar.